It's my pleasure to introduce Dr. Dennis Chen. He is my partner in crime at the University of Chicago, and he's going to try to review some of the ASGE and other society guidelines pertaining to ERCP. All right. Good afternoon, everybody. Thank you to the course directors for inviting me to come up and speak and for putting together this excellent weekend for everybody. So I was tasked with going over some of the ASGE and other societal ERCP guidelines. I tried my best looking through the agenda beforehand, looking at what topics were already going to be covered so that hopefully there's not too much overlap. But my objectives here are to review some of the key points in the existing ASGE and other societal guidelines for ERCP, review guideline recommendations for ERCP cannulation and sphincterotomy techniques, and we'll use guideline recommendations to identify appropriate utilization of ERCP for various conditions, including cholangitis and post-liver transplant anastomotic strictures. So to start, the question of who should perform ERCP? This is an important question because as everyone who is doing this knows, there are substantial learning curves associated with ERCP. We also know that experience and clinical volume are associated with technical success and clinical success. Sachinwani's group studied advanced endoscopy fellows back in 2015, and their data actually suggested that even after completing a fourth-year advanced fellowship, consistent native papilla cannulation may not yet be achieved. This is their graph of it. It is a little bit beyond my statistical knowledge, a Q-sum graph. But is there a pointer on this thing? There's a stop button. So essentially, this zero is where everybody starts with a baseline of no skill. And this bar is the bar of competence. And so you can see as the graph shows of the five fellows, one of these fellows very quickly achieved competence and maintained it. The three of the other fellows over the course of the year crossed into the competent phase and were able to maintain it. And then I don't actually know the story of the purple fellow who, I don't know if they had to take a leave of absence or ended their year early. But this is for cannulation in general. And then over here, as you can see, a lot more variability over the course of the year. But this is for native papilla cases only. And as you can see, again, everybody's starting at zero and wide variation. We have one fellow who seemed very proficient and stayed very proficient throughout the year. And then over here, you can see other fellows ranging significantly over the course of the year in their success. And the success was both what happened on a clinical level as well as based on their faculty's assessment of their performance. So the bottom line of this is that learning ERCP is challenging. The good news with this data is that they eventually followed all of these trainees out into their first full year on faculty. And what they saw is even if they had not achieved the full consistent competence at the end of their fellowship, they continued to steadily improve once they became faculty. And all of them ended up doing very well. As far as the ASGE goes, the guidelines for privileging, credentialing, and proctoring to perform GI endoscopy from 2017, they've stayed pretty soft on their discussion of ERCP. And essentially what they've said is that they recommend that at least 200 supervised independent ERCP procedures should be performed before learning competency is assessed. And that ideally at least 80 of these should be with independent sphincterotomies or native papilla cases. And again, this isn't even a matter of doing 200 to perform ERCP. The idea is it takes 200 independent ERCPs before you can adequately even assess the skill and competence of the person learning ERCP. But again, they've stayed away from any firmer recommendations as far as numbers needed to continue to practice, to remain credentialed, to remain privileged at an institution. They have generalized recommendations in the guidelines for all endoscopy suggesting that hospitals should have uniform and kind of clear objective guidelines for determining who gets privileged and monitoring clinical outcomes to determine who should continue to have privileges. But again, while you can talk to different faculty who may suggest certain numbers and things like that, and as all of my co-faculty who have advanced fellowship programs know, fellows coming into the fourth year are constantly asking how many ERCPs, how many ERCPs. ASG has declined to set a firm number as far as what you need to be able to perform ERCP. Moving into how to perform ERCP, the ASGE actually does not have a set guideline out right now about specific cannulation and sphincterotomy techniques. But the ESGE did put out some guideline recommendations in 2016. So we'll go through some of the guidelines they recommend, bearing in mind, again, ESGE, not ASGE, but I think this is a good framework to follow. The ESGE recommends guidewire-assisted technique to reduce the risk of post-ERCP pancreatitis. This is in comparison to contrast-assisted cannulation. For performing sphincterotomy, they recommend using mixed current due to decreased risk of bleeding compared to a pure-cut current. And they also give definition for a difficult cannulation. So they define it by one or more of the following criteria, more than five contacts with the papilla, more than five minutes spent attempting cannulation, or more than one unintended pancreatic duct cannulation or opacification. So if you meet these criteria during a procedure, this is considered a difficult ERCP. Additionally, in difficult cannulation cases where repeated unintentional pancreatic duct access occurs, they recommend pancreatic guidewire-assisted biliary cannulation, also known as the double-wire technique. So I said that ASGE didn't have formal guidelines for it. But if you go through some of their guidelines, in particular the guideline on post-ERCP pancreatitis prevention strategies from earlier this year, you'll actually find some recommendations for ERCP cannulation technique that really largely mirror what the ASGE has recommended here. So again, they also, the ASGE also recommends wire-guided cannulation over contrast-guided cannulation, again, to minimize the risk of post-ERCP pancreatitis. This is a conditional recommendation with moderate quality evidence. For this recommendation, they reviewed 15 randomized controlled trials, including over 4,400 patients. And what they found is that guidewire-assisted cannulation actually has a relative risk of 0.50 compared to contrast-assisted access. No other differences were found in adverse events of bleeding or perforation. But again, this significantly reduces the risk of post-ERCP pancreatitis. Interesting side comment they made on this is that actually they did not make a consensus on sphincter tome positioning within the duct prior to wire manipulation. So this is a question of whether or not you engage your sphincter tome into, how deeply into the papilla or duct before attempting wire access versus kind of being right on the edge of it. And they didn't place a consensus largely due to variation within the studies that were available. And a final suggestion and recommendation they put is that the guidewire should be advanced by an experienced operator. And this is based on data from Dr. Buxbaum's group looking at ERCP wire manipulation by the endoscopist versus by a technician. And that study suggested that endoscopist control of the wire reduced the risk of pancreatitis. I think there was a fair amount of editorials and commentary about this, especially from expert high-volume centers talking about that with an experienced technician handling the wire. They have similar rates as endoscopist controlled. So again, the overall guideline recommendation is to have an experienced operator. I know a lot of the folks who are attending the course here are folks who are learning and training on ERCP. And so for especially anyone who's a nurse or a technician handling this, this is a really important part of your role because this is a place where you have a lot of responsibility and power with the patient. This is a challenging thing to learn for all of us. But that kind of tactile feedback that you learn as you manipulate the wire can play a very critical role in avoiding guidewire-related injury. Going back to the ESGE guidelines, this is now talking about some of the more advanced techniques and situations. So they do suggest that if pre-cutting is necessary, needle knife fistulotomy is the preferred technique. So this is needle knife fistulotomy as opposed to a pre-cut needle knife sphincterotomy. And so the distinction here is that with the needle knife fistulotomy, you are taking the needle knife and moving typically superior on the ampullary mound to the area where you know the trajectory of the bile duct to be and basically creating a tunnel into the bile duct access rather than going in from the papilla. Obviously these are techniques that have been shown in expert hands to be safe and effective but the recommendation from ESG is that techniques like pre-cutting should only be used by endoscopists who already achieve selective cannulation successfully in more than 80% of their cases using standard techniques. So the idea would be that if you are doing your 30th or probably even your 300th ERCP, it may not be the best idea to just pull out the needle knife and start cutting away. This is the kind of thing that you should feel safe and comfortable referring to a high volume center. ESG also says that when PD access is possible, placement of a PD stent is suggested prior to pre-cutting. Another consideration that they recommend for patients with a small papilla where you are having difficulty gaining biliary access, consider a trans-pancreatic biliary sphincterotomy if PD access occurs. So this technique would be getting access whether with a wire or a stent in the pancreatic duct and then inserting the needle knife alongside that stent and cutting the intra-panc, intra-ampullary sphincter to gain access into the bile duct. Again, prophylactic PD stenting is suggested for this situation as well. Additional special situations which I think we'll go through a little quicker. For patients who have anatomical or clinical contraindication, for example, coagulopathy where sphincterotomy cannot safely be performed, endoscopic papillary balloon dilatation is suggested as an alternative to extract small CBD stones less than 8 millimeters. In patients with periampullary diverticulum and difficult cannulation, PD stent placement followed by pre-cutting or needle knife fistulotomy are suitable options. This is just a guideline recommendation to reinforce what I think all of us who do this are aware of is that when you have a periampullary diverticulum, kind of all bets are off with your conventional techniques. And here I've got a video if we can get it to play of one of these cases that I dealt with. So this is a patient who has, as you can see, a mostly intra-diverticular ampulla who had symptomatic choledocal lithiasis. I had brought her for a procedure, and during the first procedure I was able to get into the PD, but could not get biliary access. And I actually opted to leave her alone, give her a couple of days to cool off and bring her back rather than jumping into a pre-cut or a needle knife fistulotomy. As you can see, once I brought her back, I left the PD stent in place, and after a couple of days, some of the swelling around the ampulla from my initial manipulation had gone down, and I was able to get a wire, maybe not this moment, I think that first wire, Flora, was just me pushing into the diverticular space. But eventually, I was able to get a wire into the bile duct. And again, talking about your conventional approach being off, with the diverticulum in place, your bile duct trajectory can be very different because you don't always know which direction around the ampulla it's going to course. And so, your natural tendency of going towards 10 or 11 o'clock and angling up may not work in these peri-diverticular cases. Here, I think I have now successfully into the bile duct, and we're able to advance the wire, and now we see our wire happily making its way up into the bile duct, getting some contrast in there to confirm biliary cannulation. And then, I think, in the interest of time, I can skip me performing the sphincterotomy, but suffice it to say, we were able to cut a sphincterotomy, clear the stones, and the patient ended up doing well. The one final special situation that I mentioned, in patients who are undergoing pancreatic sphincterotomy, routine biliary sphincterotomy is not recommended, and this should be reserved for patients who have coexisting biliary obstruction or a separate indication to perform biliary sphincterotomy. So now, we're going to get into when to perform ERCP in the situation of cholangitis. And so the ASGE published a guideline on the management of cholangitis in 2021. There were three key recommendations in the guidelines. Recommendation number one, for cholangitis, ERCP is recommended over percutaneous trans-hepatic biliary drainage, or PTBD. This, bear in mind, is a conditional recommendation and based on what they felt was very low quality of evidence. But this was something that they made a guideline recommendation. When they compared ERCP versus PTBD, one notable thing is there is a significant lack of any head-to-head studies or randomized studies for this. But when they reviewed the available data, no difference was seen in mortality, no difference was seen in successful biliary decompression, and no difference was seen in overall adverse events, although the adverse event profiles were different between PTBD and ERCP, as you might expect. And so here we can see, again, successful decompression, ERCP, 97%, 94% for IR. Mortality is 4% and 6%. And then for total adverse events, this didn't reach statistical significance, but for ERCP, 5% adverse events compared to 10 for IR. And for PTBD, the primary driver was bleeding with 8% of cases compared to 3 for ERCP. And then, you know, I thought this was interesting that ERCP was 3% associated with pancreatitis and PTBD actually had a 2% association here as well. ERCP was associated with a shorter hospital stay. You can see that down here at the very bottom, where ERCP had an average of a 10.4-day hospitalization, whereas patients undergoing PTBD had a 23.2-day hospitalization. They also noted that while the data did not necessarily strongly recommend ERCP as being superior to PTBD, the patient advocate who was on the committee during the guideline recommendation strongly preferred ERCP, citing a variety of things, including not having to have an external drain, as you might imagine, and citing the importance of shorter hospital stays. This is the table showing, again, the hospital stay. And again, we talk about the reason they talk about how this is, relatively speaking, lower quality evidence. For everything they were doing, they really only had three studies that compared hospitalization data that they could use for their meta-analysis. But you can see here, obviously, a significant decrease, significantly shorter stay for patients who underwent ERCP. Recommendation number two, ERCP should be performed within 48 hours of presentation. And again, this is a conditional recommendation with very low quality of evidence. Why? Because there are no direct randomized control trials for this. But they did have a systematic review and meta-analysis that had been done, I believe, two years prior to this guideline being written, which was the basis of a lot of the data that they had. And so ERCP performed within 48 hours, was associated with decreased inpatient mortality. And you can see here, they reviewed separately the observational studies, as well as the database-based studies. And in both studies, this reached statistical significance. So there was no difference in 30-day mortality when they compared the data. But inpatient mortality was significantly decreased when ERCP was performed within 48 hours. This also decreased overall length of stay by 5.6 days. And again, this is hard to extrapolate from retrospective data, but it certainly seems intuitive that that length of stay reduction goes beyond simply waiting out the weekend and waiting the extra 24 to 48 hours. There have been a handful of studies that have examined ERCP at different intervals, so ERCP within the first 24 hours of presentation, ERCP between 24 to 48 hours of presentation, ERCP beyond 72 hours, so on and so forth. And the studies looking at the earlier intervention show shorter length of stay, but no impact on mortality or other core clinical outcomes. And so the, a little bit facetious, but the benefit of this is that if you are on call over the weekend and you have a stable, and the keyword is that they are stable and responding appropriately to medical management, patient with cholangitis, you can feel comfortable that this patient, if they are stable and remain stable, can safely wait until Monday to do the ERCP. Now again, in the guidelines they kind of emphasize the same thing, that this is not dogma, this is not a way to universally defer all procedures. There are always situations where patients may need an ERCP more urgently within 24 hours within that first 36 hours, a variety of factors obviously including their clinical stability and other factors. So recommendation number three, biliary drainage should be combined with maneuvers such as sphincterotomy and stone removal versus simply performing stent placement alone. Because again, this is a conditional recommendation based on low quality of evidence. And what they found when they reviewed the data is that the more aggressive approach, so performing sphincterotomy, performing stone removal at your index procedure was associated with a shorter hospitalization, but also with an increased bleeding risk. However, they noted a limitation is that the existing studies that they reviewed do not consistently report the post-ERCP bleeding rates at the subsequent ERCP when stent placement alone was done. And so essentially the patients who just had a stent placed for decompression, they did not have reliable data on when they brought them back to remove the stent and then cut the sphincterotomy and completed the stone extraction, what was the bleeding rate at that point and did it actually reduce compared to the patients who had it at the index. Ultimately no mortality difference was identified between the two methods. And I think we can probably skip this video. I think we've all seen enough cholangitis videos, so in the interest of time. Dennis from the virtual audience, they wanted to get a little bit more specific. So for you to come in, what needs to be happening to the patient? And specifically they mentioned in their hospital, the ICU attendings call them in the middle of the night and say, you have to do this within two to four hours. What is your response? I usually have a conversation with the ICU attending, and I let them know that the patient needs to be adequately resuscitated. And again, this is a conversation. We're all working to try to take care of the patient. I let them know that this is not about me being unwilling or uninterested in coming in. It's again about appropriately coming in when the patient needs the procedure done. At every institution, right, there are variations depending on if you're coming in over the weekend, what is the staffing availability? What is the crew that you have with you? Do you have your dedicated staff and are you using your normal floor of the room? Are you doing this in the OR on a C-arm with an on-call general GI team who may have no familiarity with your procedures? The other area, now this hasn't been studied in the cholangitis data, but for GI bleeding data, right, they have shown studies that intervention too early within the first 12 hours, 24 hours, can actually be associated with worse outcomes. And again, this is extrapolation of the data, but the concern would be that these patients are not adequately resuscitated before you bring them and intubate them, sedate them for a procedure. And so I kind of similarly reinforced the importance of adequately resuscitating these patients. I was going to say, I just got called on one, and they hadn't even started the antibiotics yet. So I'm always, you know, get those, that first and foremost with the fluids and everything. All right. So next situation of when to perform ERCP, looking at patients with post-transplant anastomotic strictures. So this is another guideline that was published earlier this year, ASGE guideline on management of post-liver transplant biliary strictures. Again, recommendation number one, ERCP is suggested over PTBD for management of these strictures. Again, a conditional recommendation, very low quality of evidence. This was a striking number to me, and I don't know that anyone really understands the real number for it, but these post-transplant patients with strictures who underwent PTBD rather than ERCP were associated with a significantly higher odds of transplant failure and an adjusted odds ratio of almost 8.5. Again, this is mostly retrospective data, and so I think the idea would be that perhaps the patients who are undergoing IR procedures may have been sicker to begin with compared to the ones who are stable enough to undergo ERCP. But this is conjecture, but it is a striking number. PTBD also was associated, again, with longer hospitalization and overall cost for patients. And there was no difference in technical success. One study that they reviewed did find that fewer total procedures were required using ERCP to achieve resolution of the stricture. Recommendation number two, covered metal stents are recommended over multiple plastic stents for initial therapy of extra hepatic biliary strictures. Again, this was a conditional recommendation, although they did have low to moderate quality of evidence for this one. Ultimately, what they found is that there was no difference in stricture resolution. And notably, this is actually different than my personal experience. This is a new thing learning for me, too. In the studies that used metal stents, the metal stents were placed for a predetermined period of time, usually between three to six months, and then they were removed regardless of the cholangiogram findings, while the plastic stents were continuously exchanged until resolution was noted on cholangiogram. And that hadn't been my practice with the metal stents. I was still using a cholangiogram to determine if I needed to replace the stent. So this was a new thing for me. But again, there was no difference in stricture resolution. And in the available follow-up they had on the patients, there was no difference in stricture recurrence between these two groups. And then so, as you can imagine, fewer procedures and stents were used in the metal stent group based on this. Another consideration, there was no difference in stent migration between the groups. I know obviously there's been some spirited discussion over the weekend about migration concerns with various metal stents and plastic stents and which brand of stents and so on and so forth. There also is limited data on cost effectiveness, but overall it appears to favor metal stents. There's not direct data available on hospital costs and things like that, but when they look at procedures and device utilization and equipment utilization, it does seem to favor metal stents. So this was a quicker, more straightforward recommendation. But for liver transplant patients with suspected stricture, MRCP is suggested as the diagnostic test of choice as a conditional recommendation based on moderate to high-quality evidence. ERCP was used as kind of the criterion standard. And so if the ERCP clangogram identified a stricture, the question was, did the MRCP also identify the same? And when they reviewed the data, MRCP correctly, I diagnosed a post-transplant biliary stricture with a sensitivity of almost 95% and a specificity of over 90%. Recommendation four, in post-liver transplant biliary stricture patients undergoing elective ERCP, in whom complete biliary drainage is technically challenging to achieve, periprocedural antibiotics are suggested. Again, we've had a lot of discussion about what each of us do with antibiotics in some of these high-liver strictures, PSC cancer patients. And this is another population where procedural antibiotics have, I think, long been standard because these are immunosuppressed patients who have undergone liver transplant. But again, they actually went with a fairly soft recommendation. And this is just for patients with complete biliary drainage when it's felt to be technically challenging to achieve. This is another conditional recommendation based on very low quality of evidence. When they reviewed the available data, the overall incidence of infections was 1.1%. And they could not find any evidence that routine antibiotics lowered the risk of infection or other adverse outcomes. Again, in this situation, the existing data is limited. The committee ultimately recommends an individualized approach for antibiotics, most notably considering patients who are pretest probability for poor biliary drainage, so patients who already are known to have underlying ischemic clangiopathy, patients who have strictures at multiple locations, or patients who had failed stent placement, and considering that these patients should be given periprocedural antibiotics. So that about wraps it up for me. To summarize, for ERCP cannulation, guidewire-assisted technique is the recommended approach to reduce risk of post-ERCP pancreatitis. For patients presenting with cholangitis, ERCP is preferred over PTBD and should be performed within 48 hours of presentation with sphincterotomy and stone removal in addition to stent placement when possible. For patients with post-transplant anastomotic strictures, ERCP is recommended over PTBD and covered metal stents are favored over multiple plastic stents. And then my final takeaway point, the reason I kept putting in what the recommendation level and quality of evidence was, as you guys can see, more high-quality research is needed in many ERCP situations. This is just the reality is that we lack good prospective randomized controlled trial data for a lot of these situations that we're facing. Obviously these committees are doing a great job using the data that's available to come up with these guideline recommendations, but there are limitations when the data that you're working with has those limitations. All right. Thank you.

ERCP guidelines

cannulation techniques

sphincterotomy techniques

cholangitis management

post-liver transplant anastomotic strictures

MRCP