All right, good morning, everyone. I hope you had a little time to stretch your legs, get some coffee, and we'll get started in the interest of time. Also remember, we have more than half of you joining us virtually, so our next session, we'll switch gears from AI to the real world in biliary and pancreatic endoscopy. Our first speaker is Dr. Praveen Chahal, who you guys know, was at Cleveland Clinic. She just recently moved to University of Texas at San Antonio. She's a distinguished, Steven Shanker, distinguished professor of medicine and chief of GI at UT San Antonio, and she's gonna talk about practical tips to treat large bile duct stones. Good morning, everyone. Thank you so much to the course directors and ASGE for giving me this opportunity. So these are my disclosures. When we talk about management of large bile duct stones, generally we are talking about one of these three techniques. About 80 to 85% of the large common bile duct stones you can treat with a good, generous phendrotomy and balloon or basket sweep, or adding an endoscopic papillary balloon dilation to it, different type of lithotripsy, and finally we'll talk about the role of stents, metal and plastic, in managing large common bile duct stones. As we all know, patients who present with gallstone, symptomatic gallstone, up to 18% of them can have concomitant CBD stones. And regardless of presence or absence of symptoms, these stones should be removed. Why? Because the likelihood of complications like pancreatitis, jaundice, cholangitis, it's there, and it increases with the increasing size of the stone. So for example, if a stone is less than five millimeter in size, the risk of this complication is about 5%, but data shows if the stone is more than five millimeter in size, the risk of complication can be as high as nine to 10%. So imagine somebody with large stone, which is defined as stone more than 1.5 centimeter in size, the complication rate is even higher, sometimes up to 15 to 20%. So therefore, whether patient is symptomatic or not, we should take care of these stones. Can we play the video, please? So let's start with endoscopic papillary large balloon dilation. So it was first reported in 1990s. The combination of endoscopic papillary large balloon dilation with a submaximal sphendrotomy was reported in 2003. And since then, there are numerous randomized control trials and more than 5,500 patients who have been studied and reported from this technique. So this is a technique that works beautifully. However, it is unhelpful, especially if you are dealing with patients with an impacted stone or they have a really distal stricture, and I'll share a case with you later on. One thing I would like to point out in this video, since the topic is practical tips, whenever we are doing balloon sweep, try to maintain the axis of the sweep with the bile duct. Don't try to go perpendicular. What do I mean by that? You notice we are coming right from under, and then we are bringing the balloon and sweeping it down. You are maintaining the axis with the bile duct. And the little bit of a tip away of the big wheel and a little bit right where clock is all that's needed to bring the balloon out and remove the stones. So when we are doing endoscopic papillary balloon dilation, some of the key questions we should be asking that helps us in coming up with our management algorithm is, one, how do we determine the size of the duct? How do we determine the size of the stone we are dealing with? Because that may affect on what type of technology we may employ. What size of dilating balloon should we use if we are planning on endoscopic papillary large balloon dilation? And finally, should we use baskets or balloon to remove the stone? So determination of the size of the duct and or the stone, it's easy when you take into account the size of the scope. Now, this is a beautiful on the fluoroscopic images, a short scope position. Dudenoscope, on an average, is about 12 millimeter in size. And you can extrapolate the size of the duct based on the size of the dudenoscope. Now, when we think about what size of dilating balloon we should use, the duct size that you are looking at is not the maximal, but the distal bile duct. Distal bile duct size is what determines the size of the balloon that you're going to use. And then we'll talk a little bit about balloon versus basket. So let's say now we, in that particular case that I showed before, we estimate the size of the duct to be about 13, 14 millimeters. Stone appears to be close to that range. The size of the balloon you should be using is what the distal bile duct look like, about 10 millimeter or so, not 14 millimeter. So size of the balloon, anywhere from 10 to 18 millimeter based on the distal bile duct. How long should we keep it inflated? I personally inflate it till the waste is gone. If you look at ESG guidelines, they say about 30 to 60 seconds. So anywhere from till the waste is gone to up to a minute is okay. A word of caution on leaving it inflated longer. Some people, they tend to leave it a little bit longer with the premise that it may reduce the risk of post-papillary balloon dilation bleeding. There is study which shows that if you leave it inflated for three minutes or longer, the risk of pancreatitis is higher. So don't keep it inflated beyond 60 seconds or a minute, I would suggest. Another word of caution, especially if you are noticing a calcified stone on fluoroscopy, try not to dilate next to the stone. See if the stone is not impacted, try to push it up before you inflate the balloon fully. If it's a soft cholesterol stone, the risk of ductal trauma and perforation is less. But if it's a calcified, jagged stone, then yes, there have been reports of perforation from large papillary balloon dilation. Another thing, if you are planning just based on our initial cholangiogram, and now you know that you are dealing with a 15 millimeter or so stone, start with a submaximal sphenotomy. So just cut about one third to one half of the maximal extent. Don't go full. If we go full and then we are going up with 12 to 15 millimeter balloon, that's where perforation will happen. Can you do just pure papillary balloon dilation without sphenotomy? Yes, in select scenarios. What I mentioned here, somebody who just recently had cardiac stent place is on antiplatelet, anticoagulant therapy, or somebody with autoanatomy like B2. Again, because of that large study that was published, which showed increased risk of pancreatitis in somebody who didn't have endoscopic sphenotomy. So you always keep that in mind, you know, the medical legal aspect of it. I wouldn't do just large endoscopic papillary balloon dilation without sphenotomy, unless you are dealing with these two scenarios. And if you do, needless to say, rectal endomethasin, load them up with LR and PD stent where appropriate. So another question is, should we use balloon versus basket for once you remove the stone? Again, I think it boils down to personal practice, and this is what ESG also recommends. Limited data shows they are both equally effective. There are some pros and cons, balloon versus basket. If you're using a balloon, obviously very easy, you can get a really good cholangiogram, there's no risk of trapped basket, they come in different sizes, eight to 20 millimeter based on the manufacturer. Balloons work really well if you're dealing with a lot of sludge and stones less than centimeter in size. But if you have a really dilated duct, more than two centimeter and you have a tiny stone, you don't get a good deposition next to the wall, and that's where it may not be that effective. Baskets, they do add fluorotime, they add time to the procedure. You can get a cholangiogram, but really not as good as you do with balloon. Of course, the risk of trapped basket is there, so have a salvage mechanical lithotriptor. In the endo unit, if you are planning on doing mechanical lithotripsy or using the baskets, they come in variety of sizes, two to four centimeter, and as I mentioned, again, it boils down to personal practice what you use. My go-to always is a balloon, and I do use basket in select circumstances that I mentioned. So what do guidelines tell us? ASG recommend that in somebody with large common bile duct stone, we should perform submaximal endoscopic sphincterotomy followed by large balloon dilation rather than just a full sphincterotomy alone. And these guidelines were based on data from nine randomized control trials where they showed a combination of submaximal sphincterotomy with large balloon dilation was superior in achieving overall clearance. There was less need for mechanical lithotripsy to remove the stones, and adverse events were also fewer compared to endoscopic sphincterotomy alone. So moving on to lithotripsy. So when should we use lithotripsy? Usually we think about lithotripsy if we are dealing with stones that are more than two centimeter in size, stones that are above stricture. A common example that we get in our endo unit is post-liver transplant with an asthmatic stricture, and now there are stones above the stricture. Again, different ways you can achieve lithotripsy. Mechanical is usually the first one, most cost-effective, followed by EHL or laser. Again, depends upon what you have in your endo unit. So mechanical lithotripsy has been around since 1980s, and there are different type of mechanical lithotripters that are available in the market. There is a good article in GIE about different lithotripters and baskets and balloons that are available. So if you guys want to look at what the availability is, I encourage you to look at that article. Some of them are integrated. They come in different types of format. Some you crank the handle, as shown here. Some are like pumping with like with balloon, do for the gun for the balloon dilation. Some are through the scope, which are 10 French. Some are out of the scope, which are 14 French. So different combinations and the permutations of the mechanical lithotripsy and baskets. Make sure the ones that you are using are also compatible with the basket that you have. Mechanical lithotripsy is successful in more than 90% of the cases in fragmenting the stone. As I mentioned, it's cheap, it's available. Procedure is usually simple. There are some factors, however, that can lead to failure. And ones that have been shown and studied are if you are dealing with a really large stone, more than two centimeter in size, if the duct is quite small, or there's a stricture, we are not able to open the basket fully and engage the stone. And another word of caution is, if you're dealing with a patient who has a hard calcified stone that you can see on fluoroscopy, I mean, these are the stones where I would, I don't go with a basket at all. And these are the ones where the risk of basket getting trapped is highest, because basket doesn't have the strength to break these highly calcified stone, and it just creates a groove. Baskets gets impacted, and now you have either broken wires or impacted basket situation, which you have to salvage. So if you see a calcified stone on fluoro, go directly for EHL or laser. Complications can happen. The dreaded one is the basket impaction or fracture of wire. I've had patients where there was a broken handle, and that usually happens if we are cranking the handle really fast. So this is where you're talking to your tech that go slow, you know, a handle crank one step at a time. You are not going like really at a rapid pace. This is where the wires can break and the handle can break. Perforation or injury to the bile duct, hemobilia, and cholangitis are other complications. Just sharing this case with you that happened. So I've had two cases in my career, 16 years of career, where there was an impacted basket. One during my training, advanced year 2007. Needless to say, that was a really PTSD-causing case. And the second one happened about 10 years ago. So I'm very cautious if I'm dealing with a really large stone, which by that, I mean 1.5 centimeter in size. I try endoscopic papillary large balloon dilation first. If not, I are on the side of EHL or laser. So this was a 23-year-old female who had a 15 millimeter CPD stone. The basket got impacted. So even though we had done a generous sphindrotomy, stone didn't come through, the basket got impacted. We tried to do 15 millimeter balloon sphindroplasty to see if that'll help extract the basket. That failed. And then we tried the Sohendra lithotriptor, which is outside the scope. You basically, you cut the wires off the basket and then you advance the sheath of the mechanical lithotriptor from the outside. Well, guess what? The mechanical lithotriptor got stuck also. It was not able to break the stone. So what we ended up doing is the patient had the mechanical lithotriptor wires and sheath coming out from the mouth. It was taped. Patient was admitted. Antibiotics. We brought the patient back two days later. Edema had settled and we were able to extract the basket. So sometimes just, even the salvage therapy cannot work. And this is where just waiting a couple days may be helpful. If you are able to leave a stent, leave a stent in. This was totally a trapped situation. There was no space to leave a stent. The second case that I had was a 63 year old with symptomatic stones. So not always it's the case of a large pile duct stones where the baskets get trapped. Look at this case. This is barely eight, nine millimeter duct. And you have about seven, eight millimeter stone. We used the retrieval basket and that got stuck because it was a very dense calcified stone. And again, same situation. We tried everything. Rat tooth, mechanical outside the scope lithotriptor. The wires broke outside patient's mouth. We placed a seven friend stent in the patient. Patient was admitted. Brought back two days later. The basket had passed out on its own. So just something to keep in mind even with the salvage therapy situations can happen. So we talked a little bit about the mechanical lithotriptor. They're available in through the scope and outside the scope. The through the scope are obviously longer outside the scope. They are shorter in length. It's good to have these in our endo unit to deal with the impacted basket. So moving on to EHL. Very high success rate. Adverse events can happen in up to 10%. Some of the same ones as we talked about with the mechanical lithotripsy. Benefits are really compact equipment. It's inexpensive. You don't need a special training like you do for a laser. And can we play this video please? So cholangioscopy itself is pretty simple and easy. It's a 10 friend system. You can advance the cholangioscope over the wire. This is a case of a large common bile duct stone seen on a cholangiogram here. The decision was made to proceed with the EHL and a good visualization. The key here is keeping the probe at about a millimeter or so from the stone. You are not in direct contact. You are keeping it about a millimeter from the stone and you are about four to five millimeter out of the biopsy channel. And you pick a spot. Usually it's in the middle. You are staying away from the walls. You are doing continuous saline irrigation and trying to maintain the visualization and you continue to deliver the shocks. I personally start with the power of about 50. I think the newer machines have preset power levels low and high. We have the older machine where you can adjust the power. I start at 50 with lower number of shocks and then you can continue to go higher, go up to 100 because some stones have a little bit more cholesterol component to it than the calcium. And you don't want to go with the full maximal power wattage from the get-go. Once the stones are broken down, the removal again boils down to either you use the basket or the balloon. In this case, there are multiple jagged fragments. It was easy to wrap a basket around after the maximal sphintrotomy and extract the stones. So now the question is should we take another look with the cholangioscope after clearing or get another cholangiogram? I usually personally do to make sure there are no retained fragments because in up to 15 to 20% of the times, you can see retained fragments that you can remove. Laser lithotripsy is another. If you have that in your unit, a little bit more expensive. So you are delivering a pulse laser energy at a certain wavelength targeting the stone. Different settings. We do have a homeom laser. High success rate, complication rate is very similar to EHL. Can you please play the video? Again, the principles of using laser within the bile duct are the same. I think everybody may have different template for the institution. At our institution, we do require laser training and certification before we use that. Obviously, everybody is wearing their safety goggles. The probe itself is the same size as the EHL probe. And it looks prettier though. You have this nice blue, minty blue light that comes on. It looks like you're doing deep sea diving. And it's easy to, again, the principle is try to focus on one area. Usually, it's in the middle of the stone. Oftentimes, you are creating a tunnel which eventually leads to fragmentation of the stone. So what does the data show? EHL versus laser. I would say both are effective. It's what you have in your endo unit. But when we look at the data, this is the study published in CHL. Both EHL and laser were effective. But laser was a little bit faster in terms of breaking the stone down. And it was able to achieve the stone clearance in one session more frequently compared to EHL, and this is what we see in our practice also. It's just a little bit faster and gets the clearance faster in one session. Obviously a need for multiple. And this is a study I'm quoting from one of the speakers coming up later, James Buxbaum, who looked at laser versus rest of the methods, like mechanical lithotripsy, large papillary balloon dilation. Needless to say, laser outperformed these, but one thing I would like to point to you is look at the basket impaction here, 22%. So it's not that rare when it comes to large stones. Some of the practical tips when we're introducing the EHL or laser probe, wet the probe before we introduce it through the cholangioscope. Obviously continuous saline irrigation. We talked about keeping it at a distance. If we maintain contact, this is where the probes, they burn out faster. So you will run through two or three probes if you are in contact with the stone. If you are using a lot of saline, usually I just start with a 250 ml bottle so I know how much I'm using, not 500 ml. But if you think you are using a lot of saline irrigation, you may want to intubate the patient. And again, start with a lower wattage and give periprocedural antibiotics. So just last case here, I'm gonna share 36 year old male with factor 13 deficiency, symptomatic CBD stone. And I got an MRCP. What you notice here is a filling defect. But another thing you notice here is, so there's a proximal CBD dilation and then the distal CBD is quite narrowed. So already you see that there is a stricture at distal bile duct. This is what we saw on the cholangiogram. Duct is not that dilated. About six to seven millimeter and then you have about six millimeter or so stone. We tried to do balloon dilation. You notice the balloon waste is not defaced. We did a full sphindrotomy. This is where it depends. You have how much time you have. We chose to put in a fully covered metal stent. And five days later, patient comes back with cholangitis and this is what we see. Despite fully covered metal stent, patient had a significant bleeding. We removed the clots, identified the source of bleeding and then tried to take care of the stone. Notice how tight the stricture is again. We did another attempt at balloon dilation. This is maximal balloon dilation, eight millimeter which was the size of the stent and size of the duct. And this is where you know that you will not be able to clean the stone out and cholangioscopy was helpful. Can you play the video please? So when we did the cholangioscopy here, obviously it helps with few things. You're looking assessment of the stricture. You're taking the direct cholangioscopy biopsies and also doing an EHL for the stone removal. So quick word about stents. Again, you use this if you have failed to achieve clearance. Patients with multiple comorbidities. Studies have shown that it's helpful in over 80% of the patients. Risk of migration cholangitis can happen. And even though a lot of us we use in combination with Urso, it's not something recommended. Urso is not recommended by ESGE. Both covered and plastic stents, they work. Even a single seven French plastic stent is helpful in reducing the number of stones and the size of the stones. According to ESG, it's recommended you use two double pigtail plastic stents if you want to use that for stone management. Generally a fully covered 10 millimeter and a short length fully covered metal stent also works really well. So to wrap it up, ladies and gentlemen, multiple modalities available to treat a large common bile duct stone. Each have their pros and cons. This is the algorithm that is practical and usually I follow based on the stone size and whether you fail with the papillary balloon dilation or you're dealing with a distal stricture or you're dealing with an impacted stone. And you can move on to large balloon dilation, add a mechanical lithotripsy or directly to EHL versus laser. Again, don't forget the rule of plastic or metal stents. Thank you so much. It's my pleasure to introduce our next speaker, Dr. Jim Buxbaum, who's Associate Professor of Medicine and Executive Director of the Digestive Disease Institute at the University of Southern California. Thank you, Jim, for being here today. Thank you for the opportunity to present at the ESG and our course directors today. So post ERCP pancreatitis was recognized very shortly after the introduction of ERCP. Classically, it's been diagnosed using the consensus criteria, which include increased or development of upper abdominal pain, enamelase and lipase occurring three times at preliminary normal 24 hours after the procedure and either admission or hospitalization for two nights. However, it may be underdiagnosed. Recently work using patient-reported outcomes at scale for acute pancreatitis, which is validated overall for acute pancreatitis from all causes, show that when a number of patients who had very high scores after ERCP were not diagnosed technically with post ERCP pancreatitis. About five-fold more patients had these high scores of pain, nausea and other symptoms than were diagnosed, which suggests that we may not be catching all the patients who have PEP. Similarly, the cotton consensus criteria use the number of days of hospitalization in order to diagnose whether it's mild, moderate or severe. And indeed, when the revised Atlantic classification is used, which is more for acute pancreatitis in general, we find that actually correlates better with things like mortality. So this does present a major burden, which is why it's a core part of our ASG course today. It's the most frequent endoscopic complication. Meta-analysis suggests it happens in 10% of patients overall and 14% of those at higher risk. Now, one feature that you see in meta-analysis over the years, which is not budged, is that it is fatal in one in 500 patients. It's costly and it causes a great deal of stress, as Dr. Keswani demonstrated in a study. So preventing it is a very high priority in the endoscopic community. So the number one way to prevent it is not to do the ERCP. So we really want to avoid diagnostic ERCP. Indeed, when we revised the ASG clinical thysis guidelines, we really focused on those criteria that led to diagnostic ERCP. Total bilirubin alone, or bilirubin and dilated duct, were not strongly predictive. And then a lot of patients ended up having just diagnostic ERCPs without a benefit. And so we revised the criteria. We required both a high bilirubin and dilated duct for a patient to go directly to ERCP. And indeed, unless they have this or deafness to own imaging or cholangitis, they should get an MRCP or endoscopic ultrasound first. But the goal, to avoid unnecessary ERCP. And indeed, EOS prior to ERCP reduces a risk of post-ear-speed pancreatitis by threefold. So ERCP is the therapeutic procedure. And we have very good alternatives that are safer for diagnosis, namely MRI, EOS, and maybe interoperative chlangiography. Also avoid sphincter-votoid dysfunction type three. So SOT3 are these patients who have right upper quadrant pain, but do not have abnormal liver tests, do not have abnormal imaging. Peter Cotton, in his great paper in the episode, showed that when randomized to a sham or sphincterotomy, looking at disability at three, six, and nine months is the outcome, that there was actually no difference, and there's actually somewhat better outcome for sham patients. 37% were better versus 23 with the treatment. And so this should be avoided. And indeed, even in the episode trial, 12% of patients did develop PEP. So now let's get to the meat of the matter, how to prevent post-ear-speed pancreatitis. So the first mechanism of this illness is you irritate the pill enough that the pancreas duct and the pancreas do not drain well. So what are these technical risk factors? Difficult cannulation, we all experience this, our pulse goes up as our number of attempts go up, because we know that the risk of PEP goes up directly with the number of cannulation attempts, up to 12% after five attempts. And as the time goes up, more than five minutes, you're approaching 12% as well. Other things also, like pancreatic sphincterotomy, contrast injection, balloon dilation without sphincterotomy are also culprits. Patient risk factors, Dr. Marty Friedman's here today, who really defined this in his seminal New England Journal paper. These include things like suspected sphincter roti dysfunction, female gender, young age, and a normal bilirubin. So I had the great opportunity to work on the ASG guideline with Dr. Friedman and Dr. Kamsaya and others, and we had an opportunity to really delve into that evidence and perform a number of systematic reviews of the best preventive strategies, which I'll really focus on for the rest of this talk. So pancreas stents, the way they work is when you have an inflamed papilla, here's a case where I'm trying too hard and it's getting swollen and angry and you're in the pancreas duct, it doesn't drain and the fluid goes back into the gland and causes trouble. So a pancreas stent allows a conduit to drain more happily into the duodenum. And indeed, a meta-analysis of 17 randomized trials showed that the PEP reduction is three-fold for pancreatic stents, and it's five-fold reduction in severe pancreatitis. We did this as part of the guideline. And we didn't see an increased risk in perforation or injury due to placement of stents, and it was also quite cost-effective, at about 9,000 per quality-adjusted life year, which is good given you need to be 100 still reasonable. It was especially important for severe pancreatitis. There were actually no severe cases in the randomized trials, in the arm of the randomized trials in which patients had a pancreatic stent, which is 13 in those that weren't stented. So the AHG did recommend the use of PD stents based on this analysis. And you can see here is another one of my cases that makes you a little nervous. You can see we filled pretty far here into the tail. And indeed, contrast injection is a risk factor, and the more you fill, the worse it is. So this led to the idea of wire-guided cannulation. So the idea with wire-guided cannulation is you're in a duct, you pass a wire instead of inject to see where you are. So as part of the guideline, we did ask Francis Say to update her Cochrane meta-analysis. And indeed, it still does reduce PEP to use wire-guided rather than contrast-guided cannulation by twofold. A couple copied, so we did do some analysis on this. And interestingly, if patients had pancreatic stents, there was no difference. And we also looked at whether it's important to pass a wire first or pass a tome first. And it appears that the benefit is really if you have a tome to pass the wire after the tome is already in position. So I think the idea is if you're digging around with a wire and you don't place a pancreatic stent, that's probably more of a problem. So the issue did suggest wire-guided cannulation over contrast-guided cannulation. We looked at this, in my group, looking endoscopist versus system-controlled wire. Modern syringe or tomes allow you to control the wire yourself. And we were really trying to see whether this improved cannulation. But during an interim analysis, we actually were halted by the statisticians because there was an increased risk of PEP in the system-controlled arm. And we hypothesized this is likely due to lack of tactile feedback. If the endoscopist runs the wire, you can feel the duct better and be a little bit more careful. And I think this is really important if there's a lot of turnover in staff and nursing and technicians especially, if you have a very established team of 10 or 20 years experience, this probably doesn't matter as much. Other technical approaches, early pre-cut reduces PEP, but really only in the hands of experts. When they look at novices and trainees doing this, there's not a benefit. And the idea is that you cut earlier in a cannulation attempt rather than trying for half an hour or something that you pre-cut with the first five minutes. Dual-glide wire is a widely used technique. This is, you can see an image on the right where you have a PD wire and then you cannulate the bile duct. This actually is a technique that actually increases the risk of posterior speed pancreatitis, probably because you're wiring the pancreatic duct too much. So it's a good meta-analysis. I think this is problematic, again by Francis Say in the Cochran database. I'd advise that you probably should be thinking about a pancreatic stent if you do have a long-dwelling wire like that or you're repeatedly accessing. Okay, so that's the technical part. Now let's think a little more of the patient part and the medical part of this illness. So what happens in posterior speed pancreatitis is once you traumatize the papilla and the opening of the pancreatic duct is that you have activation of pancreatic enzymes in the astinite, you have astinite cell injury, and then you have immune cell activation. So you work through this cascade. And so we've tried unsuccessfully primarily to stop this using a number of agents. For papillary trauma, we tried epinephrine spray and Botox, not helpful, to prevent the enzyme activation, Noctreotide and protease inhibitors have been used with kind of mixed and not really convincing results. And for the immune cascade, there's been a number of attempts, including most prominently use of steroids and also free radical approaches with things like N-acetylcysteine. So not super helpful, but there is a death valley after a super bloom. You can see there's a flower growing out of the basin. And probably the brightest light in this part of the field has been with NSAIDs. Murray et al. did the first big single center study with the clofenactarine improvement, reduction in PP, and then Joel Munzer in his New England trial showed that there is a reduction of moderate and severe, as well as all posterior CP pancreatitis with the use of rectal endomethysin. And this was in a high sphincter vodae population, which probably wouldn't be done as much anymore. As part of the AHG guideline, we reviewed this, and indeed, there was 18 trials in unselected patients and 10 in high risk. It appears that there is a two-fold reduction with rectal NSAIDs. One issue is that rectal endomethysin has gotten very expensive. It's gone from about $2 to more than $3, and now some people even say $500, $600. So you may use alternative strategies like compounding diclofenac. Other considerations that these studies really excluded the really low-risk patients. So the recommendation may not apply to things like a biliary stent exchange. But overall, given the preponderance of evidence, the AHG does recommend the use of rectal NSAIDs in unselected and high-risk patients. How about, can you just throw away pancreac stents now that we have rectal endomethysin? So Joel Munzer did do a post-hoc analysis and saw that they appeared similar, and there was a network analysis that showed that maybe rectal NSAIDs are better than stents, which did lead to the stent versus endomethysin trial, which I had the great honor to be part of, along with a number of others in this room. This was a major effort, and so 1,950 patients were randomized to rectal endomethysin versus rectal endomethysin plus a pancreac stent. And the goal is to show non-inferiority, and so you can go back to our college statistics. And so for non-inferiority, the idea is you don't want to cross a preset upper bound of a confidence interval. And so it's 5% for SVI, and actually it was crossed. In fact, the attention tree analysis, it also crossed zero. So it actually showed that there was superiority of pancreac stents plus NSAIDs versus NSAIDs alone. And at this combination, when post-hoc analysis looked at the number of risk factors, for patients at the greatest risk was even a stronger protection of pancreac stents. The risk difference was 24%, and it was really, really high risk patients versus more like 3.3% for the more moderate or lower risk folks who had things like difficult cannulation. So the message is you need your pancreac stents. So there's one of the rivers in southern New Zealand that I saw during my honeymoon. It kind of gets you thinking about aggressive hydration. So the idea here is that in pancreatitis, there's decreased regional decrease in flow in the pancreas during more severe pancreatitis, and these regions correlate with more intense necrosis. Additionally, in patients that are under-resuscitated, cohort studies show that there's an advantage of more plentiful resuscitation. And so we and others did randomized trials looking at this, and it does appear that they're protective, although there is an important caveat to note that if rectal NSAIDs are combined with fluids versus rectal NSAIDs alone, there may not be such a difference. We can see this from the FLUTE trial, and they did not show a difference in PEP with aggressive hydration in patients who'd received NSAIDs in both arms. There was a trend, though, with the revised Atlanta towards possibly less moderate and severe RAC-based pancreatitis. There is a caveat, though, that the study wasn't necessarily powered to show an incremental benefit. It was powered to show the same kind of benefit as either NSAIDs alone or fluids alone. Additionally, I had the honor of working on the Waterfowl trial with Enrique de Medara, and we looked at aggressive hydration overall for pancreatitis, and actually the trial was stopped because there was more volume overload to the aggressive arm. And while we didn't reach, you know, we were only at 33% enrollment to show a difference in main outcomes, there didn't appear to be a huge benefit of the fluids either, so it's kind of getting us to think more globally about this and in question a little bit more. But for the HG guideline, when we did look at the totality of evidence, including the FLUTE trial, there was about a two-fold protection with aggressive hydration with the L-lactated ringers. In terms of implementation, cost effectiveness of this work does show that it is expensive. It's more than 100,000 if you do account for a 24-hour admission to get fluids for moderate-risk patients. For high-risk patients, it's about 30,000, so it may not be of use for all patients pending a different strategy, such as using more bolus-type administration. The HG just suggests, but it's more of a conditional recommendation to use aggressive hydration. Now, there is a lot of interest in combination therapy like we see with blood pressure control or treatment of HIV and other things, and interestingly, nitrates overall have had kind of a mixed record, but recently there has been a couple studies showing that when you combine with rectal NSAIDs, there may be benefit. And I would argue that already, most endoscopists are using combination therapy of combining stents and indomethacin and hydration so that we are using multimodality approaches. Looking to the future, it is becoming somewhat of a golden era in the treatment of acute pancreatitis as a whole. There's new drugs that are being trialed. At this ACG meeting in 2024, the results of the CRACK inhibitor study with the CM4620 is gonna be presented, which has completed a multi-center international trial to target pathologic calcium signaling. There's an ongoing study of free fatty acid injury inhibitors with lipase inhibitors that's ongoing, the RABI 767 study, and this is for acute pancreatitis in general, not just post-CRCP. There's also a department defense study of statins for acute pancreatitis. And also, there's human studies ongoing and TLR media, total microcephalic media inflammation. So I think if these studies hit, it does show a benefit with acute pancreatitis treatment that very rapidly this will be used in the preventative role for posterior CP. So in conclusion, the diagnosis of posterior CP pancreatitis, it's probably underdiagnosed using patient-reported outcome measures. There are a lot more symptoms in patients that get caught by the cotton consensus criteria. Probably revised Atlantic classification is a better way to understand the severity. It is a morbid disease. It's the most common complication with endoscopy. It can be potentially severe and is stressful for the endoscopist. Prevention is definitely critical. Most importantly, avoid ERCP when it's not necessary. It's not a diagnostic procedure. For indeterminate stone patients, you could do your MRI first. Avoid SOD3 ERCPs, as there's not a lot of proven benefit. Recognize the technical risk factors. If you have difficult cannulation or pancreatic injection, this should trigger a warning while you're doing the case. Think strongly about pancreatic stents, especially in these cases. They're a very powerful tool. Use them in high-risk cases or if you're accessing the pancreatic duct repeatedly. Remember that rectal nemethicin cannot be used instead of a pancreatic stent. We know this pretty clearly now from the STI study. And then use a wire-guided rather than contrast-guided cannulation, although I think we need to still figure out whether the tome leads a wire or wire leads a tome. In regards to prevention and patient risk factors, be very wary in those of suspected sphincter dysfunction and those of normal diameter. Pharmacologic therapy, rectal nemethicin should be considered in high-risk and unselected patients. Aggressive hydration is promising, but probably more for inpatients or those at a little higher risk given it takes longer. Hopefully there are ongoing studies looking at bolus therapy, which should be informative. Future work is also needed to study combination therapy. And I'm excited to see if the new acute pancreatitis agents, such as crack inhibitors, may have a role in posterior speed pancreatitis prevention. So it's going to be a brighter day in this field, thanks to the work of many. Thank you very much. Thank you, James. Thank you very much, James, for that great presentation. Our next speaker is Dr. Raj Keswani, who's Director of Endoscopy and Professor of Medicine at Northwestern University in Chicago. Thanks. Amen. All right, I obviously want to thank Michelle, Melanie, and Irving for this kind invitation. You know, I don't want to thank them for making me follow James, who did such a tour de force of post-ERCP pancreatitis, which is a component of quality in ERCP. But it is hard to follow him. If you paid attention to his lecture, you heard that he spent his honeymoon thinking about aggressive hydration and pancreatitis. And with that kind of commitment, it's hard to compete against that kind of talk. So I will try to be a little bit more sort of broad overview of what we need to be thinking about in quality in ERCP. So first I want to go through why we should care about ERCP quality, and then what we can do to improve quality now, and that will include the safety of ERCP as well. So why should we care about ERCP quality? And we've seen very nice videos from Praveen of how things can be challenging in ERCP. And in the first session, we talked a lot about colonoscopy quality. But ERCP quality to me is one of these things that is desperately needed to be focused on because of the impact on patients. So I like to think about endoscopy quality in general in this way, right? So if we think about an individual patient, maybe it's a family member of yours, and unfortunately they were diagnosed with early stage pancreas cancer. And they go see their oncologist, and they're offered drug A or drug B. You usually just don't go say, all right, I'll just take drug A without any questions, based on the color and the packaging. You might ask relevant questions like, what is the treatment-related mortality? What is the efficacy of this medication? These are natural questions we ask for medications that we give patients for serious diseases. But when we change it to endoscopies A or endoscopies B, it becomes a black box. We assume that everyone who does an ERCP does it equally well. Everyone who does an EUS does it equally well, even though we know there are very significant outcomes differences based on who does your endoscopic procedure. And this is extremely important in procedures like ERCP. So this study came out a decade ago, but I find it really illustrative of how important focusing on ERCP quality is. These were inpatients who underwent ERCP. And if you had an unsuccessful ERCP as an inpatient, your odds ratio of dying, which I would argue is a very important quality metric, was 1.7. So that is a strikingly higher risk of dying after an inpatient ERCP compared to when you had a successful procedure. And so this sort of thing makes us think, well, this is not to belittle finding polyps in colonoscopy, but this is an outcome that I think we can all get behind, that we need to do a better job of making sure we have successful and safe procedures. So for this reason, both the ASGE and the ESGE have focused on that important basic step in ERCP, which is getting into the ductive interest. The old ASGE guidelines have a performance target of 90%. I like the way the ESGE has put this. They said you should be getting into the ductive interest 90% of the time, but we should have a target standard, which is we ideally would strive to 95%. And there's a lot we could talk about where trying to get too good is more difficult. So if I'm trying to persist too often on a case and trying to get to that 99% success rate, I may be causing more harm than good. But I think we can all agree that this 90% at minimum is a metric we should try to achieve. So how are we doing in the US? As everyone knows, we are very independent in the United States. We don't always like to be told what to do. So we unfortunately do not have a mandatory registry on outcomes and performance. We did do a study a few years ago about looking at how people who'd finished advanced and DOSB fellowships and then went into independent practice, how they performed in things like ERCP quality. And that was actually heartening, right? So if you look at the frequency with which they in their first year of independent practice successfully got into their ductive interest, it was 93%. So there were some former trainees who did not meet that metric. They were also able to remove common biotic stones and place stents, other ERCP quality metrics that were the ASGE priority quality indicators. So in these highly trained recent graduates, most of the time they were achieving high quality ERCP in independent practice. But there are ERCP quality lessons from outside the US that are a little bit more concerning. This is a nice graph that shows on the X-axis how many ERCPs you're performing in practice. And on the Y-axis, this is procedural success. And overall, the procedural success rate in this initial registry from 2015 showed that the ductive cannulation success rate was about 86%. But what's more concerning is that there's dots that are around that 86% mark, that there's people who are getting less than 80%. This was updated to a mandatory registry more recently, which they published a couple of years ago. The overall success rate now goes up to 89%. But again, I want to focus on the fact that there are many people doing, you know, moderate volume ERCP, 100 to 150 to 200 procedures that are not making that 90% target rate. So it's not really that we all want to achieve an average of 90% for our population. We want to get everyone to a minimum of 90%. So in this study, it shows us that we still have a way to go to achieve that quality metric. Part of this is going to be a volume outcome issue, right? And so we performed a meta-analysis several years ago showing that if you are a lower volume center, you're less likely to have a successful ERCP. And if you're a lower volume endoscopist, the same thing holds. So it is important, as you'd suspect, to try to actually do the procedure more frequently if you want to get good at it and maintain quality performance. And unfortunately, low volume ERCP continues to be an issue. This was a nice study done by Greg Cote using Indiana data about a decade ago. And there are a lot of providers performing infrequent ERCP. If you can look at these numbers, I mean, there's, you know, 15% of people to 20% of people are performing 0 to 20 ERCPs a year. And that, no matter how technically gifted you are, it is very difficult to maintain high quality at these very low volumes. And this is why a lot of people have advocated for centralizing ERCP care. Not to say that everyone has to go to a major center, but maybe not have four people doing 10 ERCPs a year at one practice. So hopefully in summary thus far, I have convinced you that procedure success rates vary widely and these variations correlate with clinically significant outcomes, including mortality. So now how do you improve the ERCP quality? This is much more challenging than proving we don't do a great job. So I was given the honor by the ASGE to write this guideline on how to, interventions to improve performance of ERCP and EOS quality indicators. What I didn't realize is I was probably being set up to fail because there's really little data on this, right? So in summary, I had to write this comprehensive review of the literature identified a paucity of evidence-based interventions to improve ERCP and EOS quality indicators. Really there's scant evidence on how to ensure that ERCPs were performed for the appropriate indications and when performed, how to reliably improve technical clinical success. I would say over the last few years, a lot of my colleagues in the room have done a much better job of really advancing the field and giving us high quality evidence on how to improve ERCP. But historically, this has been a very anecdotal retrospective approach to how to improve quality. So how do we improve ERCP quality? Here's what I can tell you that, you know, we can see in the literature and we know, right? So James touched on this a little bit, but I'll emphasize indications again. How do we improve cannulation? And then I'm going to highlight some of the things that James presented as well on reducing adverse events. So this is arguably one of the most important things we can do. We can perform ERCP only for appropriate indications. But I know from our very comprehensive literature search, I know of only one abstract that has actually looked at how we can improve the performance of ERCP for appropriate indications and that was simply by one center auditing the indications field and saying, hey, by the way, I think you did an ERCP for the wrong reason. And they showed that people stopped doing it for the wrong reason or more likely they stopped writing down the wrong indication that says they're doing it for the wrong reason. So unfortunately, there's not a lot of data of how to get people to do ERCP for the appropriate indication. So example of quote unquote bad indications, you know, this was touched on, biliary type pain in the setting of normal liver chemistry tests and a normal bile duct, diagnostic ERCP for low probability of colodocal lathiasis, diagnostic ERCP for PSC, although this is mostly, there are very occasional times where we do diagnostic ERCPs to, you know, rule in or rule out PSC. And then unnecessary repeat ERCPs, people who get a stent placed for no reason after clearance of stones and then have to come back for another ERCP again. These are sort of bad indications. This is highlighting James' work showing the ASGE guidelines on how to determine whether the patient has a high or low probability. This is interesting because even these high probability patients, and I know that the authors would agree, even patients with high probability, some of them don't have a stone anymore. So in my personal practice, I add another row here, which is persistent pain. If they're having pain still and these high probability predictors, then I'll go straight to ERCP, but I have a very, very low threshold to make sure that there's a stone there. Not always because, you know, I want to be sure that there's a stone in someone with abdominal pain and persistent, you know, and persistent LFT elevations, but if the procedure becomes difficult, I need to know how much to escalate this intervention, right? If I'm not getting to the bile duct right away, I really want to know that there's a stone I'm chasing rather than someone who passed a stone an hour before the ERCP began. So this is a way to think about how to manage CBD stones that then reduces your dependence on unnecessary ERCP. So again, if you have a low probability of CBD stones, you should be sending your patients for a surgeon who will reliably do a lap coli with an intraoperative quangiogram. If they're not doing intraoperative quangiograms for these patients, they're doing a disservice to the patient. If there's intermediate probability, you can consider an EUS. I often think about if it's Friday, I'd rather do an EUS and plus minus ERCP than find out that night on an MRCP there's a stone and have to come back in on Saturday to do it. So I think EUS is very reasonable for intermediate probability. And again, high probability, I will go straight to ERCP if there's persistent pain, but if they're pain-free, I'll do a quick EUS just to make sure that the stone hasn't passed. But we can talk in the Q&A about what other people's practice is in this population. So how do we improve cannulation success rate? I showed you how important that was before. What data is out there? This is sort of a summary of all the things that is data-driven to improve cannulation success rate. There is data out there showing that prone position improves success rate compared to supine or left lateral, although there's more recent data since we published this suggesting this may not be true in all hands. So I would suggest that this is something to consider, but it may be operator-dependent. Deep sedation does improve cannulation success rates compared to moderate sedation. If you find that you're having difficulty with your ERCP success, making sure you have anesthesiology support can help you. I think all of us know now, but sphincter tomes are preferred compared to cannulas in terms of improving success rates. Obviously there will be outliers who use cannulas with high success rates, but on aggregate this is what has been found in literature. We talked a little bit about physician-controlled wire-guided cannulation, and there's actually very limited data on how we can actually educate people using mechanical simulators, and it's mostly been in trainees. So what to do with someone who doesn't perform at a high level to improve them is unclear really in practice, and that's an area of ongoing research. And there is low-quality data to support advanced cannulation techniques to improve success rates, but that's primarily in a high-volume endoscopist. Whether you can suddenly tell someone who does 10 ERCPs a year that they should start doing complex, advanced maneuvers to get into the bile duct, whether that's beneficial or harmful is unclear, but I would suggest it's probably harmful. I think that one of the things that we've been focused on is really just understanding that ERCP is an accumulation of skills, like all endoscopic procedures, and we've seen this in the surgical literature. What this basically means is that, you know, we don't want to just focus on the outcome of interest. We want to actually focus on the technical skills to get people to success, and so this is work that's been led by Joel Munzer to sort of break down the ERCP procedure into its technical skills components, and we've sort of talked about this concept that maybe we can have people actually understand the reason that they're not performing the ERCP in an optimal manner and actually help them achieve success. So rather than just telling someone your accumulation success rate is 75 percent, please do better, actually understanding visual cues of, you know, how to line up the papilla, how to engage the papilla, how to use the guide wire appropriately, this sort of education that we've delivered to trainees may be useful to practicing endoscopists as well. So what are the advanced techniques that we should know to improve our success rate? You know, in the interest of time, I'm just going to go over the concepts of these. I think everyone knows this, but just to understand, double guide wire is sort of, at this point, a basic technique that you should have in your practice if you're performing an ERCP. This is the idea that you leave a guide wire in the pancreas duct and you cannulate over the guide wire. In my personal practice, I generally prefer doing this first rather than placing a pancreas stent and cannulate over the stent because occasionally you can have a small orifice and it's difficult to engage the papilla because the stent has taken up the papillary orifice. So double guide wire, you need to be very facile with use of the guide wire and you need to be very safe with it because you can cause a lot of damage by inappropriately placing a guide wire in the pancreas duct. Similar to that, cannulate over a pancreas stent, which is a technique that we should all know in practice for performing ERCP. And then a needle knife, either with a sphincterotomy, and for technical purposes, that means you're starting at the orifice and cutting up towards the apex, or starting towards the top of the papilla and cutting down, which is called a fistulotomy. A fistulotomy has actually been sort of proposed as the safest approach because it basically eliminates the risk of pancreatitis altogether because you're coming nowhere near the pancreas or the orifice. So in my practice, this is the native anatomy algorithm that I think is helpful to improve our cannulation success rate. Once you get to that difficult biliary cannulation, we need to figure out whether it's difficult because we're not able to reach the papilla. If that's the case, then you need to consider colonocoduodenostomy or hepaticogastrostomy if expertise is present, or percutaneous biliary drainage. But if you are able to reach the papilla, sometimes it's just changing to a tapered cannula, or doing pure wire guided cannulation, or even changing to the long position. So persisting and doing the same thing is truly the definition of insanity. So you need to think about what you're going to do next. And you'll see them even in live courses when you watch the true experts. They're always thinking about, if this doesn't work, what do I do next, rather than doing the same thing over and over again. And sometimes, again, it's just simple changing of device or changing a position. If you're able to cannulate the PD, and especially if it's been a few minutes and you finally get into the PD, please do not remove the wire. Leave the wire there. There is nothing more frustrating than watching a trainee rip out the wire as soon as they get in, as if the dwell time of the pancreas wire is what's going to cause pancreatitis. If you're in the pancreas duct, leave that wire in and use it as an aid, with or without a stent. I think once the stent is in, it's a lot easier and safer to consider a needle knife if you need to. Again, US rendezvous may be considered in these patients. And in patients who have pancreas cancer especially, but can be used in all patients, I do like this idea of a trans-pancreatic sphincterotomy. This is the idea that you're in the pancreas duct and cutting towards the biliary direction to help you get into the bile duct. So another technique that you can consider in practice. If you're unable to cannulate the PD, I tend to not like US-guided rendezvous for a bile duct stricture, because there are times where you can't get the wire to cross. In those cases, I would consider a freehand needle knife. But if US rendezvous is a backup, if there's no bile duct stricture present, I would consider US rendezvous or a freehand needle knife. But again, this is all just opinion. I think getting a sense of what on this algorithm that you feel you can perform in your practice can be particularly helpful as you start to think, what am I going to do next if this doesn't work? And so I can be very brief through preventing post-CRSP pancreatitis, because James covered this so well. So we can stay under time. Again, we talked a little bit about endomethicin, stents, or both, and intravenous fluids. I'm just going to highlight what James said. Endomethicin reduces post-CRSP pancreatitis risk in this important New England Journal of Medicine study. I think everyone in this room knows it. It's protective across an entire range of pancreatitis risk. So it's not just the very high-risk patients. It's also the people who are at somewhat elevated risk. Whether it's helpful for people with very low risk is still a little unclear to me. We can talk about that in the Q&A. The big issue is that we're not optimally using endomethicin. This was a nice study from Zach Smith and colleagues, which basically showed, even in 2018, about five years after the New England Journal of Medicine study came out, only 50% of patients were getting endomethicin. And this is a quality issue. When you see a variation like this, the question is, why? Why are we not doing something that we know is effective for our patients? And so how to educate people to use this appropriate therapy is still unclear. I think James talked about the stent and endomethicin, so I'll skip over the SVI trial. James talked a little bit about aggressive hydration. This is his trial, which showed that with aggressive hydration, you can get to 0% pancreatitis risk. I wish that was replicated in all studies, but it is a very nice signal that hydration works. This study, which James did not cover, I think is really helpful to think about. It's just, unfortunately, not feasible in the United States. But this is something called tailored aggressive hydration. This study came on the Red Journal from South Korea, which basically took first-time ERCP patients, so native papilla, and they randomized them to tailored standard hydration versus tailored aggressive hydration. And you can see those dosages. And you can see that, basically, they kept their patients in the GI lab for three to four hours after ERCP, measuring amylase and lipase after four hours, and assessing for abdominal pain to figure out whether they should admit them and continue hydration or discharge them. And patients with tailored aggressive hydration had a significantly decreased risk of pancreatitis. So this adds more support to the idea that that periprocedural hydration can be very helpful to reduce pancreatitis risk. But if I try to keep patients for more than one hour in my GI unit lab after ERCP, everyone gets upset. So how this gets operationalized is unclear. And finally, we just need to start measuring better. This was a nice study that showed that if we could just measure how well we're doing, give that feedback to providers, maybe we could do a little bit better job. If I just knew how I was performing relative to my peers, then we might be able to make some progress. And I think that's, hopefully, what we're going to get to with all the work we've seen before to make improvements. So in summary, I hope I showed you there's wide variability in ERCP performance, impacting patient outcomes. And there are efforts to improve the quality and safety of ERCP. And these should focus on reducing unnecessary ERCP, improving success rates, and reducing adverse events. Thank you. You can just sit there. You can sit in the crowd and I'll go. All right. A lot of you are here, and this is the time of the debate. So we thought we will not leave you out of the debates. Not everything in endoscopy is black and white. So we thought we would get some controversial topics, see where we are. So before I invite the next speakers, we all deal with hyaluronic tumors. How many in this room routinely place plastic stents? How many of you routinely place metal stents? So it looks like a little more number for plastic. All right, we'll see what our next speakers will show the evidence, where we need to do, and how we can modify or improve our practices. The first speaker is Dr. Martin Freeman, who oh, you're going second. Sorry. The first speaker is Dr. Raj Shah. Sorry, he's here. All right. Raj will be speaking about the role of plastic stents in hyaluronic tumors. Raj is from the University of Colorado School of Medicine. Welcome, Raj. Thank you very much for a kind invitation to address you today. For full disclosure, I'd like to declare that Dr. Freeman sent wake-up calls to me from midnight until 5 AM. So I'm a little bit tired, just choking around there. So plastic stents, what do we got? So my debate goals is to try to convince you, maybe, that plastic stents carry a simpler medical decision tree with a high rate of technical success. Their re-interventions are more feasible. They allow for additional segment stenting, add PTBD if needed. The type of malignancy and the patient condition really does matter. Use plastic stents until you know for sure what the disease and management plan are. And in resource-rich health systems, such as many enjoy here in the US, advances in medical therapy of hyaluronic malignancies have shifted the paradigm from metal to plastic. So these are some of the common causes of malignant hyaluronic strictures, cholangiocarcinoma, local extension from these malignancies, and metastases to the lymph node or liver metastases. And this can shape the decision on type of stent and also medical therapies. So which of these hyaluronic malignancies should undergo drainage? Palliative biliary drainage may not be beneficial in patients with poor performance status who have short life expectancy. If they're resectable, preoperative drainage does not reduce mortality and actually can increase morbidity related to infectious adverse events. The goal, preoperatively, may be to drain the future liver remnant. And really, this is best done in conjunction with a multidisciplinary team at high volume centers, specifically with hyaluronic malignancies. If there's cholangitis, prolonged jaundice, or anticipated delay in surgery, then drainage is recommended. So the ACG clinical guideline on managing biliary strictures, this was recently published a year or so ago. And we think about segments and draining more than 50% of the non-atrophic liver. So it's very important to look at that non-invasive imaging prior to pursuing ERCP. The goal is to alleviate symptoms or reduce bilirubin to permit chemotherapy. There's really, they declared insufficient evidence to recommend for or against plastic or uncovered stents. But I'm hoping to convince you there's plenty of evidence here. And then palliation can be considered a little controversial, but PDT or RFA with plastic stents may be better. So what's the basis of this debate of metal versus plastic stents? And this is a study meta-analysis looking at re-intervention rates. And you can see with metal stenting showing a reduction in the rate of re-intervention. But this is from data from over 10 years ago. And things have changed in the sense of medical therapy. Advances in immunotherapy, chemotherapy, targeted therapies, they've changed the paradigm. Patients outlive their uncovered metal stents. And limitations, this one study of over 25-year tertiary center practice, over 300 patients, only half of whom received adjuvant therapies, which here in the US, it could be even higher than that. The adverse events included migration, occlusion, in-growth, all things that we see with uncovered metal stents. In the ASG guideline on managing malignant hyaluronic strictures, they also mentioned that patients in their RCTs who were randomized to plastic stents did not undergo scheduled stent exchanges. So this led to potentially earlier stent occlusions, higher adverse events, and hospitalizations that could have resulted in worse survival. So these are not great options for patients with long life expectancy, these metal stents. So this is a 73-year-old presenting with acute right upper quadrant pain, found to have acute cholecystitis. Ductal dilatation, elevated LFTs. To me, this is high criteria for bile ducts down, pursue ERCP. So I did the ERCP, and it actually showed a hyaluronic stricture. And I placed a plastic stent after brushing. Hyaluronic stricture turned out to be malignant. This is a CT scan that was done. This was end of the day on a weeknight and pursued ERCP prior to cross-sectional imaging, but an ultrasound had been done. So the CT showed a tail of pancreas mass, as well as a liver mat in the right liver. So the bilirubin reduced, but they represented a week later with fever and pain. A plastic stent was placed because we didn't know the diagnosis. And we were able to access the left side, and the patient did clinically well. And we do this appropriately, plastic stents. But occasionally, there are patients. This is a patient that was seen at an outside facility that had a partially uncovered metal stent for presumed malignancy. And you can see in the upper aspect of that stent that there's tissue ingrowth. So my first reintervention was placement of a fully covered metal stent and two plastic stents to assure drainage, thinking that the stent-in-stent technique would assist with the removal of this partially covered stent. It didn't work. I had to use cholangioscopy-guided laser ablation of the ingrowth, and then place a covered metal stent, eventually removed it. Look at that, ERCP number six. Number seven, I'm putting plastic stents, finally stent-free. Unfortunately, seven years later, just in the last three months, it came back with a hepatic abscess, and the stricture had reoccurred. This could be stent-related. It could be post-coli-related, but a good example of where we don't want to use permanent stents in cases in which malignancy is not documented. The recent Asia-Pacific consensus on malignant hyaluronabstruction, bismuth two to four, they state clearly in this group of experts. In East Asia, certainly, and South Asia, see more malignant hyaluronabstructions than we do here in the US. If systemic chemotherapy is planned, and multiple plastic stenting with scheduled stent exchanges may be preferred over metal stenting, consider metal if patient's not a candidate for who has failed systemic chemotherapy. This is a widely recognized group of experts. 92% completely agree or agree with some reservation, which I thought was pretty good. There's some challenges with plastic stents, and you have to use the right kind. The ones that are polyurethane, or if they're a mixture, or a hybrid of silicone and polyurethane blend, they tend to retain better in the enteropatics with less risk of migration. This is an elderly person with a liver mass that was adeno-CA. PTBD was attempted, but they were unable to internalize it. They were worsening jaundice. They were transferred for ERCP. You can see dual plastic stents that are placed here. They failed to improve significantly, and in fact, the nice thing about plastic stents here is they were able to remove the one that's in the right anterior, where the PTBD drain was, and then target the right posterior, and then get the left lateral, and they clinically improved. So it's a good example of where plastic stents can allow you to err a little bit to then retarget the area for drainage. And then lastly, this case is a 55-year-old female. Recurrent biliary stricture was stenting for 25 years at several outside hospitals. It's now requiring ERCP every three to four months. She had an aborted surgical plan in the early 2000s due to fibroinflammatory changes found to be IgG4-related disease. And if you look at the number of metal stents here, yes, I think at least one is covered, but some of these are uncovered. There's still at least, there's maybe about four metal stents in there. And this is the clangogram on the right from when she was seen in Colorado, because she moved to Colorado recently. And you can see multiple interhepatic stones. And so she's looking at potentially PTBD, but I'm gonna try clangioscopy-guided laser ablation in this patient coming up. So I just saw her recently in the last few months. So another reminder about the stakes that are involved in placing uncovered metal stents at the hilum. So this nice algorithm, basically really highly recommend that you review this at your leisure. But if the patient has a hilar clangocarcinoma and it's resectable, then they can go on to preoperative drainage. If they don't require preoperative drainage, they can go right to surgery. If they're poor performance status, you can do ERCP. If they are, or sorry, if they don't have, if they have poor performance status and go with supportive care, but if they don't, then consider palliative treatments with stenting, potentially systemic chemotherapy, stent exchanges until they're non-responding to chemotherapy, or if they're just not interested in further treatment. So hopefully I've convinced you that maybe plastic stents are the way to go. I believe that the argument is a good one for plastic stents in the current era of advances in therapy. I think that if you're fortunate to combine deliberate experience with deep humility, you may find tranquility in accepting that there may be more than one method to solve a problem. And what one thinks to be the best way may not even be a good way. 19th course coming up for RMI next year. And I will leave you with this. Dr. Freeman's eyes are all for heavy metal, and metal's the way to go. He's rocking in the plastic-free world. So Marty, we look forward to your talk. All right. Dr. Freeman needs no introduction, has done a lot of work in the field of ERCP. He's a professor of medicine at University of Minnesota. Dr. Freeman. Yeah, I'm hoping we have a little time for discussion, too. So I have no conflict of interest, specifically no conflict with accessory companies. I have no conflict of interest with accessories companies. No conflict with accessory companies. Metal stents for holotune, when placed optimally. And that, I don't think you saw an example of that in Raj's talk, all placed elsewhere, have superiority patency, should be placed super papillary. And I mean, this may be a new concept, but it's an old one. New to you, but it's old. Y-stent allow, the stent and stent allow best repeat access. RFA can be done through Y-stents. Allow far fewer repeat interventions. And actually, I think in patients with long survival, I'm gonna show you two cases which hopefully will convince you metal is better. Allow adjunctive stents for gastric outlet obstruction without caging. Okay, so these are exact cases. I do not blend cases. 77-year-old male veteran, retired engineer who counts things carefully, locally advanced hyaluronic cholangio. He's been alive for four years, managed by experts with dual sector Jolin, ideal soft plastic stents. And chemotherapy, he didn't qualify for immunotherapy. 35 ERCPs for stent exchanges with 11 episodes of cholangitis. And cholecystitis, and he's transferred to our centers with his last episode of E. coli bacteremia. Here's the Jolin stents, which is great. That's what we use, too. I learned that from Raj one day years ago. But they migrate outwards like all plastic stents. What do we do now? We clearly wanna go metal, unless he wants 35 more ERCPs. And we did triple sector access, balloon dilation. Don't wanna do double. We'd wanna do double metal, but not triple. It's too cagey. We replaced the gallbladder stent because it had stones and it had cholecystitis. And then with dual wires, after dilating all the sectors, we're gonna go right anterior and left. And we do the angular one first. It's not always the left duct. And I hope you can see this, but this is his case. Open cell laser cut stent ending in the mid-duct and then the trick of this procedure is then going back through the lumen and finding the same path which you have pre-dilated into the left duct here. Then we're putting a six French open cell laser cut through that, balloon dilating, making sure everything's drained. Notice the stents end mid-duct. They're not trans-papillary and here's the result. Two stents coming together to form one. I think it's so important how you do this. So when you look at all these data, there's a mishmash of stents, techniques, placement, amount, drainage, and likewise with plastic stents. So what's happened? He's remained asymptomatic. Checked. He's back at the VA. He's checked. He's asymptomatic for the last year. So he survived five years with plastic stents. He had 31 ERCPs in four years which calculates to eight ERCPs a year plus three cholangitis. I don't know, you know, the older I get, as Peter Kahn said, the more I think like a patient than a doctor. That's not how I want to spend my life. I have cholangitis. Metal stents, one ERCP, no cholangitis. So they can have extended survival, multiple ERCPs, and episodes of cholangitis. Every three months ERCP for five years. It's a lot and it's bad for the brain to do general anesthesia and it's bad for the everything to get cholangitis. Well-placed metal stents have dramatically better patency. This study we published, this is Jolin multi-sector stents versus metal patency. You don't have to be a statistician. I didn't hear a lot of evidence for plastic stents. I heard a lot of guidelines and anecdotes and we've all seen metal stents placed and do badly. But the data support from the GIE guidelines, which were terrific, the patency of metal stents is far superior. Their guidelines recommend metal for patients with a short life expectancy or if the patient prefers avoiding it, repeat interventions. Now I would like any of you to find me a patient who prefers repeated interventions, especially when you get up to 30, 40 ERCPs. So to me it's preferred in most cases. Obviously not if you don't know if the drainage is adequate or, in my opinion, if you don't know how to put in Y stents. And this is now opinion, not data, but it's based on vast experience with all of these. Y stents have to be done with open cell laser-cut metal stents because they bend, they leave a large interstices that you can put a second stent through and it doesn't have a caging effect. It's very easy to get back into both. These spiral stents, which are the majority of the market, are actually almost impossible to do Y stents with. Our experience at the U, just the last five years, we've done 23 Y stents for hyaluronic cholangiocarcinoma. Median patency is nine months and less than one ERCP after placement average. What's the problem with side-by-side stents, which are sometimes thought to be equivalent, if they're trans-papillary? Two things I didn't hear about risk factors. The two big under-recognized risk factors for posterior speed pancreatitis. One, trans-papillary metal stent. Cote did a great study. It's very powerful. Six-fold increased risk, especially with a normal pancreas, like hyaluronic cholangiocarcinoma and hyaluronic tumors. But the other is putting a guide wire in the pancreas, and we'll talk about that later. It's actually more potent risk than contrast. And every study that's looked at it has showed it. But these cause pancreatitis, but also reflux. The problem with suprapapillary side-by-side is one always beats the other one out, and you can't get back into the other stent. There's not a lot of good data about that. So in my opinion, side-by-side metal stents, not a good idea. So this is an old idea which is becoming new again, like a lot of things. Suprapapillary stents have a longer patency than trans-papillary. There's a randomized trial this month's GIE for metal stents for distal malignant obstruction that shows dramatically better patency for suprapapillary. There's no food reflux. They don't trap food junk. Okay, so I'm gonna end with a second case and try to be on time here. 84-year-old male with metastatic prostate cancer, bismuth 2, hyaluronic cholangiocarcinoma. He was diagnosed exactly three years ago. We put Y stents after we did dual Jolens at first, which gave him nice drainage, didn't last that long, and then we switched him to Y metal stents, and then we brought him back to do RFA, and here we're doing RFA in the right anterior and here, then we easily go into the left. He also has gotten immuno and chemotherapy, worked very closely with our oncologists and surgeons and transplant surgeons, and okay, so here's what's happened to him. 1.5 years after the metal stent, we just let him be. He came back with gastric outlet obstruction. Okay, so what if he had plastic stents in there? That could be a real mess, which I didn't hear addressed, so do a dental stent. 3 years later, just recently, his wife sent us this message. Just so you know, he's still mobile, sleeping well. I mean, you can read it. Those stents must be working. We went to Canada to get her haircut. I had to contact, haven't had to contact end-of-life services. This is not typical. This, look where the guy lives. Imagine it takes six hours on a good day to get here, and in the winter, which does happen along Lake Superior, he could be in trouble. I just want to end on time with the article that I think, very proud of this, and I just published it with Mohammed Bilal, who is moving to Colorado to work with Raj and others, and he has adopted our, the exact same approach. In fact, the data we're looking at on why stents is, and RFA for hyaluronic tumors is joint with his data from the VA, so thank you very much. Great, we'll have all the speakers come up to the stage, please, and we do have some questions that came through the chat box. That does not mean that any of you cannot get up and raise your hand and ask for a question. So before we go on to the discussion, I know we had a raise of hands before the debate. How many of you now will choose plastic? How many of you will now choose metal? It's a number of people responding have dropped down dramatically. Responding of any kind. All right, so we have a lot more undecideds than we started before. Don't even say the term undecided. So I think I'm going to take a few questions and read them out so the speakers can answer. We have enough chairs. So during a difficult biliary cannulation, the wire enters the pancreatic duct and a pancreatic stent is placed. Now successful biliary cannulation is achieved during the course, and I think the questioner probably stopped there, and I think their question is, would you leave the stent, pull the stent out, Raj? Ten seconds. I think, right? Yes. So you had a difficult biliary cannulation, the wire enters the PD, a PD stent is placed, you've completed your CP, you got the stent out. What do you do with the stent? That's an easier question. I would definitely leave the stent in. I think the question would be whether or not the wire gets in briefly and whether or not you want to put a stent in at the end. There is so much data on this. Putting the wire in the PD is a bigger risk factor than contrast. Wang et al. did a beautiful study in China, published in 2008. That's a long time ago. Yes, you put a wire in the PD, especially a normal PD, that's very high risk. Leave a stent in, and there's a randomized trial of pulling stents out, immediately leaving them in. It's very bad to pull them out. You should leave them in. So is the risk cumulative or multiplicative? That's the question. If you have a stent, and yeah, they're each, well this is where the beauty of huge multivariate analysis, when they separate wire paths and contrast. They're independently significant, but the wire is a stronger risk. It's about a three-fold risk. Contrast alone, especially limited, has very limited risk. And there are excellent studies, mostly from Asia, where in guide wire cannulation, contrast makes no difference. It's putting the wire in. So if you put the wire in, and it's a great study from Japan, we put the wire in the PD, leave a stent there. Dr. Chahal, I have a question. Why do some patients have recurrent choledoacolatiasis and CBD obstruction after lap chole? Are there any recommendations to prevent further stone formation? And should you bring these patients back every three to six months to clear the duct and prevent cholangitis? Yeah, that's a million dollar question, and if you find an answer, please let us know. I don't think anybody has clearly understood the pathophysiology of stone formation. We all know the multiple factors, and some bile are more lithogenic. So if you are dealing with a patient with a lithogenic bile, I personally, even though ESG doesn't recommend, I put them on Orso. I think I extrapolate that from a bariatric literature, where patients who undergo Roux-en-Y gastric bypass, you give them even a dose, a single dose, 300 milligram of Orso per day, it reduces the risk of recurrent stone formation. And this is what I see anecdotally in my practice as well. Lithogenic bile, you have done a nice big sphincterotomy, put them on Orso Diol. Generally, I ask them at least twice a day, if not more. And if they do get it, I think that's all we can do from this, our standpoint, till we understand pathophysiology and micro-metabolomics a little bit better. We have one more question, which is, given the high cost of rectal endometrosin, can you give it orally? You know, they've done studies on that, doesn't appear to have a big benefit. But what you can do to save money is, you can get that clofenac orally, then you can compound it to give as a suppository. It's not totally known why NSAIDs are better rectally, but that's the only route where they've really shown benefit. Since you're at the microphone, I have another question. If the PD is accessed, if the PD is not accessed, injected, but the cannulation is prolonged, should we access the PD intentionally to place a PD stent, or should we just induce, should we assume that the rectal endometrosin and fluids are adequate? That's a very loaded question. So that's, as Dr. Freeman's learned too, as part of the SVI trial, we did dig into the pancreas to stent it in difficult cases. And we thought that probably caused harm, but actually it didn't appear that's totally the case. So that may... In fact, it was beneficial. Even if you, which there was a very high failure rate in the SVI trial, 20%, but with intent to treat PD stent for high risk like that, it still was beneficial to overall try to place a PD stent than to leave it alone. And that was one of the key findings of the study. Right. I just want to, you were saying... If I heard this right, you would still attempt to cannulate the PD despite the difficulty and try to stent if you can. I've started doing that more since SVI. A lot of this is how you do it, and unfortunately most people who do a lot of your, we are not trained in small duct difficult pancreatic wire and stent placement. That's something we've emphasized for like 20, 30 years, and it's on videos, ASG videos, but I think the take home from the SVI trial is everybody out there should become better and focus on how to place PD stents, not as a byproduct accident of jamming big wires around. Do you guys agree? I did. It also depends upon the appearance of the papilla, right? You wouldn't attempt to put a PD stent in. I mean, if you notice there's an obvious lot of edema at the papilla, and then again, depends what prolonged attempt leading up to it, and those are the cases. Patient has chronic pancreatitis, so several other factors determine whether you would intentionally try to get a PD stent in. Can I just make one quick comment? I think that we still need to be very mindful of experts, as you're hearing here, trying to place a pancreas stent. It is extremely challenging in some cases to get a guide wire safely into the pancreas, so you can cause more injury than benefit, especially if you're not as gifted as some of the people who are performing these studies, so I fully support that we should make everyone better, but I think we need to be mindful that persistence can make things much worse, and going out of side branch is probably worse than just not doing it at all. Certainly, you know, in the ASG guidelines, we came down strongly to put a PD stent if you have access, and you repeatedly hit the pancreas. The little bit of wobbles is when you go after the duck, and it appears it's beneficial, but as Raj alluded to, if you're difficultly doing that or not that well trained, that could lead to trouble, but ideally we'll train people to be better at it. So Raj Shah, there's a question. How do you typically deal with occluded stents to tumor ingrowth? For metal stents? Yes. So you can consider RFA of the stents, and I think that's a good role for RFA to reduce ingrowth, and then generally place plastic stents through that. I would also like to say about the wire access in the PD, though. I mean, just like contrast injection, not every contrast injection is equal. If you're filling out to the tail, that's definitely a PD injection. Same thing with a wire. I mean, if you recognize very early that you're heading the trajectory of going for the PD and coming out, I'm not sure that we have to tell our audience that they definitely have to put a stent in with one small, even couple centimeters wire into the PD. Well, again, factor in, multi-factor, young woman who had her gob bladder out for dyskinesia, who has a bile leak with tiny little ducts, and you poking around in her pancreas, put a stent in. If it's a 90-year-old with pancreatic cancer, don't. So, you know, again, you want to be flexible and adaptive to the individual patient. So Raj, there's a specific question for you. What's your approach for questionable bile leak post-hepatopancreaticobiliary surgery or trauma? Questionable bile leak. That is, are you sure it wasn't for Raj Shah? It's at Dr. Keswani. Yeah, no, I think, so this is for a bile leak after trauma. Or surgery. Surgery. This is an interesting thing to me, at least I'm curious what the panel says. Obviously, we all know for post-surgical cholecystectomy leaks, it's a short plastic stent, often with sphincterotomy to help heal the leak, because in many patients they have a coexisting stone which has caused the leak. Traumatic liver leaks, so, you know, cut surface leaks and things of that sort, much harder to heal. And if they're refractory, you then need to consider things like coiling or glue. The big thing is, in general, you need short stents that actually just drain trans-papillary, but if there is a leak, just like if it were in a pancreas duct where there's a leak actually of the duct itself, you need to traverse it, otherwise it'll never heal. So if it's a cystic duct leak or a cut surface leak, a short fat stent, but if it's a leak of the main duct of the pancreas or bile duct, you need to traverse it. Go ahead. You know, we have a randomized trial going right now. They're about three quarters the way through to question that, though, to see whether you really need to cross it or not. So I'm not totally sure. So I'd like to thank all of you. There are a lot of questions, but I think we are running a little bit behind time. These questions will be circulated by Marilyn to you, so we can get back to the people who have asked questions. Again, audience, all the speakers will be around. We appreciate the enthusiasm around these topics. Please feel free to ask them. So the lunch is here in the back. Please pick up the lunch. Don't go too far away.

biliary endoscopy

pancreatic endoscopy

bile duct stones

endoscopic techniques

balloon dilation

lithotripsy

post-ERCP pancreatitis

pancreatic stents

ERCP quality

cannulation

plastic stents

metal stents

biliary obstructions