Good evening again. Thank you for joining in. The Association of Bariatric Endoscopy Division of the American Society of Gastrointestinal Endoscopy welcomes you to this evening's presentation on a clinically important but challenging topic, ERCP after bariatric surgery, new techniques and tips. My name is Manik Agarwal. I'm a gastroenterology fellow and the incoming advanced endoscopy fellow at Mayo Clinic in Rochester, Minnesota. I earned my medical degree at Delhi University followed by a residency at Teevan Clinic in Ohio. I will be facilitating and moderating tonight's webinar and the discussion that follows after. Our speaker for tonight's webinar is none other than Dr. Nikhil Kumta, who is a renowned expert in the field of minimally invasive procedures. Dr. Kumta earned his medical degree from Jefferson Medical College. He followed this with a residency gastroenterology fellowship and advanced endoscopy fellowship training at New York Presbyterian Will Cornell Medical Center, which also included third space endoscopy and bariatric endoscopy. Dr. Kumta additionally holds a master's in patient-oriented research from Columbia University Mailman School of Public Health. He previously served as the system director of intervention endoscopy, the director of third space and bariatric endoscopy and the advanced endoscopy fellowship program at Mount Sinai Hospital in New York City. In fall of 2024, he transitioned to a new position at the NYU Langone Health as the chief of endoscopy at the Tisch Hospital and serves on the NYU faculty as an associate professor of medicine. A special thanks to tonight's webinar's course directors, ABE advisory board chair, Dr. Allison Shulman and ABE advisory board member, Dr. Mariana Papadimitriou. Before we start, here are a couple of housekeeping items to remember. There will be a question and answer session at the close of the presentation. Questions can be submitted anytime using the Q&A icon at the bottom of your screen. Please note that do not use the chat box for questions as that won't be monitored. Please note that this learning event is being recorded and will be posted on GI LEAP, which is the ASGE's learning management platform in approximately one week. You will have ongoing access to the recordings in GI LEAP as part of your registration and you can revisit the material at any time. At this time, I would like to turn over the webinar to Dr. Kumta for tonight's presentation, ERCP after bariatric surgery. To you, Dr. Kumta. Thank you so much, Manik. It's a pleasure to be here with you tonight on this webinar, which is put together by a collaborative effort from the ASGE and the Association for Bariatric Endoscopy. I want to thank the course directors, Dr. Shulman, Dr. Papadimitriou for the invitation to speak tonight and also thank you to the staff at ASGE and AIM for their contributions to the webinar tonight. I've been tasked with asking to speak about ERCP after bariatric surgery, focusing on some new techniques and tips. These timeline maps highlight the increasing spread of obesity, which is defined as body mass index more than 30. As many of us are aware, obesity is becoming a public health crisis. This is not just an issue domestically in the US, but one that is also seeing epidemic proportions worldwide. This is likely influenced by changes in diet, sedentary lifestyles, and urbanization over time with very wide-reaching consequences for public health. In particular, it's of concern for obesity-related conditions that are on the rise as well, like diabetes, cardiovascular diseases, and obesity-related cancers. There are multiple treatments that are available for obesity and they vary in terms of risk and efficacy. Most patients will start out with diet and lifestyle modifications, including exercise. Historically, medications were very low risk but not very effective. On the other end of the spectrum, we had multiple options for bariatric surgery that varied in terms of their risk and efficacy. Now, it's important to note that only a small minority of eligible obese patients actually undergo bariatric surgery for a variety of reasons. And as we are all aware now, over the last couple of years, newer medications, including the GLP-1 agonists, have really exploded onto the scene and they have very impressive weight loss numbers and there are actually more combination medications that are coming on the horizon. Endobariatrics, including intragastric balloon placement, as well as endoscopic sleeve gastroplasty, are also available to some patients, although there are limitations in terms of access because of a lack of a CPT code and widespread insurance coverage, in particular for ESG. There are also a lot of new and exciting endobariatric devices and technology that are currently in the investigational phases. A lot of these newer devices focus on small bowel therapies to address metabolic diseases. So let's take a look at the various types of bariatric surgery and the challenges that in particular ruin what gastric bypass anatomy poses. So we'll start at the top left, which is the lap band. So this is a band that surgeons will place where they have a band that goes around the serosal aspect of the stomach and it's connected to a catheter where the terminal end is a port that's placed underneath the skin by which a surgeon can loosen or tighten the band by adjusting the amount of fluid via the port. And patients are able to lose weight via this mechanism with a restrictive type of physiological weight loss. On the top right, you have the gastric sleeve or the sleeve gastrectomy. This right now is the number one bariatric surgery that's being performed. The surgeons will excise along the greater curvature and remove the fundus as well. And they will essentially turn a kidney bean shaped stomach into a more tubular banana shape of the stomach and patients are able to lose weight via, again, a restrictive type of physiology. After sleeve gastrectomy, the number two most commonly performed bariatric surgery is the ruin gastric bypass, which is on the bottom left of the screen. In this surgery, the surgeons will split the stomach into two. They'll fashion a smaller gastric pouch and then to the gastric pouch, they'll connect a limb of small bowel of jejunum via a gastrojejunal anastomosis. So in gastric bypass anatomy, when the patient eats, food will traverse down the esophagus into the gastric pouch, then cross the gastrojejunal anastomosis and go down the root limb, thereby bypassing most of the stomach as well as the foregut of the GI tract. And so patients here lose weight via both a restrictive and a malabsorptive pathophysiologic process. On the bottom right, we have the duodenal switch pancreatic obiliary diversion procedure, which is also a combination of restrictive and malabsorptive weight loss surgery. And it's not done as commonly anymore in the States or worldwide. So most common in the United States and worldwide right now is the sleeve gastrectomy on the top right, followed by the ruin-wide gastric bypass on the bottom left. And patients that undergo bariatric surgery are certainly at risk for forming biliary complications post-surgery. And a lot of this is due to the fact that there are risk factors for development of gallstones or cholelithiasis, with obesity and rapid weight loss being two of the biggest risk factors. And of patients that undergo bariatric surgery, about 25% of them will actually develop cholelithiasis. These rates are somewhat decreased in patients that are taking ursodiol. But of those patients that develop cholelithiasis, another subset of those patients, about 5% to 10% of them, will actually develop choledocholithiasis, where the stones end up migrating into the common bile duct, where they can cause problems, including biliary obstruction or even gallstone pancreatitis. And this choledocholithiasis in the post-bariatric surgery patient population is seen more commonly in ruin-wide gastric bypass, as compared with laparoscopic sleeve gastrectomy. So I think that raises the question of, if a surgeon is already in EOR, why don't they just do a synchronous or concurrent cholecystectomy? But that's actually not routine, unless that patient already has gallstone symptoms or disease because of the risk of complications associated with cholecystectomy. So what are some of the indications for an ERCP after bariatric surgery? I would say probably the most common ones that we see are stones or strictures. So we talked about the presence and development of stones after surgery because of obesity and then rapid weight loss. But very commonly, we may be asked to evaluate strictures either benign or malignant, and there may be patients that have had surgeries such as a cholecystectomy, for example, that can develop leaks afterwards that may require management. But really, we can do an ERCP after bariatric surgery for any other pancreatic biliary indication that we would for any other patient. With the restrictive weight loss surgeries, the lap band and the sleeve gastrectomy, it really doesn't require a tremendous deviation from conventional ERCP. We can use our standard duodenoscopes and standard equipment to be able to perform ERCP. The caveat with sleeve gastrectomy anatomy is that oftentimes, because the greater curvature won't be able to bow out because of the staple line, we may end up being in a shorter scope position for ERCP, and so we may have a little bit less stability than what we're typically accustomed to. But again, for the most part for these two types of surgical procedures, when we do an ERCP afterwards, it's with a conventional duodenoscope and with standard equipment that we're typically used to. Now, special consideration needs to be given to Roux-en-Y gastric bypass, so let's review some of the challenges of ERCP in a patient with Roux-en-Y gastric bypass anatomy. So as you can see, the distal stomach along with the duodenum and the ampulla are separated and bypassed from a small gastric pouch by formation of the gastrointestinal anastomosis, and as a result of the surgical anatomy, standard ERCP is difficult or even impossible in many of these cases. The ampulla is not readily accessible by conventional endoscopic methods, and oftentimes this is due to the case of having a very long length of the jejunal roux limb. Sometimes this can be greater than 150 centimeters or about five feet in length. Post-surgically, patients may also have adhesions and that can limit mobility of the gastrointestinal tract and also lead to fixation of the bowel, making it very challenging to navigate a scope to reach the ampulla. But if we are able to reach the ampulla going down the jejunal roux limb, back up the biliopancreatic limb to reaching the ampulla, we are often faced with an upside-down orientation. We are now looking at a retrograde orientation for cannulation of the ampulla, which is completely reversed from what we typically are used to with traditional antigrade approaches. And finally, with conventional ERCP methods, we also can't use our standard duodenoscope, which means we no longer have an elevator or a big working channel that we're typically accustomed to with standard duodenoscopes. So here are the options that we have for ERCP in patients that are post-word-wide gastric bypass. The three sort of mainstays for most of our patients include enteroscopy-assisted ERCP, also known as e-ERCP, or sometimes referred to as device-assisted ERCP. We also can collaborate with our surgeons and perform procedure in the OR known as laparoscopy-assisted ERCP or LA-ERCP. And then finally, with the advent of therapeutic EUS, we can actually perform an EUS and place a lumen-imposing metal stent between the gastric pouch and the excluded stomach to facilitate and integrate ERCP. And this is a procedure known as EDGE, which stands for EUS-directed transgastric ERCP. So those are the three most common ones that we'll focus on for tonight's talk. Less commonly though, we can utilize EUS-guided biliary drainage. This is predominantly via the use of a hepatico-gastrostomy. Also less commonly utilized is percutaneous biliary drainage by IR, and even less common than that is surgical intervention for biliary decompression in the post-word-wide gastric bypass patient. So we'll take a look at each of these in more detail, starting with enteroscopy or device-assisted ERCP. So conventionally in these patients to do ERCP, we have to advance our scope down the esophagus, get past the gastric pouch, and go all the way down this roux limb. And then we have to take an angulated turn at the jejunal-jejunal anastomosis and head up the biliopancreatic limb until we can reach the ampulla. And this is with essentially a suboptimal scope. We can use either a single balloon enteroscope, which is seen here on the left, or we can do double balloon enteroscopy, which is the picture on the right. Now multiple centers have looked at device-assisted or enteroscopy-assisted ERCP, and they've shown that cannulation success rates are only about 60 to maybe 70 percent, which is really not acceptable. And there are several reasons why that's the case. So an enteroscope has a camera with a frontal view, and the approach of the ampulla becomes oblique, whereas with a conventional duodenoscope for ERCP, the camera is more laterally, and the approach of the papilla then ends up becoming more frontal. Enteroscopes also have thinner working channels, which can limit the size of catheters and stents that we can place. There's also no elevator present on the enteroscopes. And sometimes because of the long length of the roux limb or the biliopancreatic limb, we have a lot of looping and we can oftentimes be in an unstable position to be able to achieve successful cannulation. We also have very limited, dedicated, quote-unquote long devices that can be passed through the enteroscopes, and it sometimes can be very challenging if you have a looped scope position to get scopes through the channel of the looped scope. Because of the working channel, which the diameter is usually only about 2.8 millimeters, we really can't place most metal or even 10 French plastic stents. So a lot of limitations when we think about enteroscopy-assisted ERCP, and oftentimes these are very long, strenuous cases that may not be successful in accomplishing the goal of cannulation of the bile duct. Another option for our patients for ERCP post-rheumatoid gastric bypass is working in tandem with our surgical colleagues to perform a laparoscopy-assisted ERCP. So more recently, endoscopists will go to the OR with a surgeon, and the surgeon will create a fashioned gastrostomy to the excluded stomach. And so in this scenario, we can put the duodenoscope directly through the trocar into the excluded stomach and access the ampulla as we would with a conventional ERCP. And so some of the advantages to laparoscopic-assisted ERCP is that we can use a conventional duodenoscope, we have very high success rates, greater than 95 percent with this technique, and it's probably best suited for patients that already need to go to the OR for another indication, most commonly being having a same-session cholecystectomy. But there are multiple disadvantages with this route of ERCP. One, it's invasive, obviously, as a surgical procedure, and that can be challenging, especially in patients that have a lot of prior surgical history, may have a hostile abdomen, may have a lot of adhesions. Secondly, doing an ERCP in the OR with the ergonomics and across a sterile field can sometimes be challenging from a body positioning standpoint, from an ergonomic perspective. The fluoroscopy and endoscopic screens may not be where we're traditionally accustomed to, and so it may result in some difficult positioning on our part to be able to successfully perform the ERCP. It's a very, very high cost to open up an OR, to perform these surgical procedures, so cost is certainly something that is at a disadvantage when you're comparing the operating room costs versus endoscopy suite costs. Logistics are also a challenge. For laparoscopic-assisted ERCP, it requires coordination and scheduling between both the endoscopy team as well as the surgical team. Additionally, if you don't have access to a disposable duodenoscope, you may have to undergo sterilization of the scope that you typically use, and that can oftentimes take 24 hours to be able to to get done, and then a lot of time is spent during these procedures in combination with surgery. Sometimes these procedures can be an hour and a half, two hours, or even longer, which is a significant amount of time for these procedures. Finally, if a patient needs a repeat ERCP, let's say you do an ERCP, you have to put a stent in, so you have to come back and be able to get that biliary stent out. In order to do a repeat ERCP in these patients, it requires the surgeons to leave a PEG tube into the excluded stomach, and then once that gastrocutaneous fistula matures, you can bring them back and essentially do a transcutaneous ERCP through a stent going directly into the excluded stomach from the cutaneous side, but that's an inconvenience and oftentimes discomfort to the patient to have to maintain a PEG tube into the excluded stomach for about four weeks to allow the gastrocutaneous fistula tract to mature before we can go back in and do a transcutaneous ERCP. So what we really need is a procedure that can be performed by a single team in a single session in a cost-effective and efficacious manner, and so this is what led to the development of the EDGE procedure, or EUS-Directed Transgastric ERCP. So the thought here was that to achieve a single team, single session endoscopic procedure, this could be accomplished by temporarily reconnecting the gastric pouch and the excluded stomach. And this would allow for performance of a conventional ERCP without having to make any new holes in the patient's skin. But historically, we didn't really have a lot of tools for this until the lumen-opposing metal stent became available. This was originally designed by Ken Binmuller from California, and it was first approved for pancreatic fluid collection drainage, but we've been able to utilize the design of this stent to be able to create a temporary connection between the two gastric lumens to facilitate passage of a conventional duodenoscope through the gastric pouch into the excluded stomach, advance it into the duodenum to the ampulla, and perform a more standard ERCP as we're accustomed to. So let's take a look at an example of a case for the EDGE procedure. So a 60-year-old woman with a history of a Roux-en-Y gastric bypass was seen as an outpatient for intermittent right of quadrant abdominal pain. She had a past medical and past surgical history of the bypass. She also had her gallbladder removed and a history of pancreatitis. She had stable vital signs and normal white counts, there was no concern for cholangitis, and she had very mildly elevated LFTs in a cholestatic pattern. A pre-procedure MRI MRCP was performed that demonstrated choledocalothiasis. So for this patient, we performed a staged EDGE procedure, and so we first accessed the excluded stomach using a 19-gauge needle, and then we put water or saline through the needle to be able to distend that excluded stomach, and essentially create a landing zone for our lumen-opposing metal stent. So there you can see the opening of the distal flange of the lumen-opposing metal stent in the excluded stomach, and then we pull back on that distal flange to create nice apposition between the gastric pouch and the excluded stomach before we deploy the proximal flange in the gastric pouch, and you can see the water that we put in that's coming out. We then dilate the luminal diameter of the stent with a controlled radial expansion or CRE balloon, and then in this case, because they didn't have cholangitis or were severely symptomatic, we discharged the patient home and then brought them back a few weeks later to facilitate an ERCP, and so we then, in a second stage, passed a duodenoscope through the lumen-opposing metal stent, advanced it down to the second portion of the duodenum to be able to perform a conventional ERCP. So here you can see cannulation of the bile duct using a sphincteratome and a guide wire, and then a cholangiogram is performed, and you can see a very large stone in the distal CVD. So then we performed standard maneuvers for removal of a large stone from the bile duct, which includes a biliary sphincterotomy, as well as a sphincteroplasty here to facilitate mechanical lithotripsy and then extraction of this large stone. So next, a trapezoid basket is advanced into the bile duct. The stone is grabbed and then crushed. Small fragments of the stone are removed when the basket is pulled out from the bile duct, and then we can go back in using a more standard biliary extraction balloon to extract the residual stones that are still within the duct. And so in this fashion, we're able to completely clear the bile duct. You can see on the repeat balloon occlusion cholangiogram, there are no longer any filling defects within the bile duct, and then the duodenoscope is carefully withdrawn so as not to dislodge the lumen-opposing metal stent. And then we brought the patient back at a later date, and we're able to remove the lambs and close the fistula. So that was a two-stage procedure to accomplish the ERCP. Now I was part of the team when I was a fellow at Cornell, working closely with my mentor Michelle Kahela, Reem Shariah, and my good friend and colleague Prashanth Kadia. And back in 2014, we described the first EDGE procedure, which was really novel at the time, to create a gastrogastric fistula, essentially to reverse the bypass via placement of this EUS-directed lumen-opposing metal stent. And this enabled us to actually perform the antegrade ERCP. And that first patient, we did it in a single-stage procedure. Now when the EDGE procedure was first proposed, there were a lot of people that expressed reservations concerning the potential long-term adverse events of reversing the bypass via that gastrogastric fistula, such as abdominal pain, marginal ulcers, persistent fistula, and weight regain. So what we did was closely followed our patients, and we published a subsequent series in GIE in 2015, which was the first five patients that had undergone the EDGE procedure in post-gastric bypass anatomy. So in that population, we used a 15-millimeter lumen-opposing metal stent. At the time, the electrocautery tip was not available, and we didn't have the 20-millimeter lumen-opposing metal stent that we do now. We created either gastrogastrostomy fistulas or jejunogastrostomy fistulas, and we had 100% technical success for the procedure. In three of the five patients, we did an index ERCP in that first session. The main issue that we ran into early on was dislodgement of the lumen-opposing metal stents. So in two of those three cases where that happened, we replaced the stent, and in another one, we readjusted the lumen-opposing metal stent back into position. But there were no other serious adverse events. And once the patients were done with their ERCP portion of the procedure, we removed the LAMs, and then we closed their fistulas using endoscopic suturing. And in that cohort of five patients, we did not see any weight gain that they experienced. So let's take a closer look at the finder points of EDGE technique. So what's been described under EUS for identification of the excluded stomach is what's known as the sand dollar sign. Now, before this description, I didn't know what a sand dollar was, so I put a picture of it on the left. It's actually a sea urchin, and it kind of does resemble what the excluded stomach looks like when it's completely deflated. So under linear EUS, you want to identify the excluded stomach, find that sand dollar sign. And then the next step is to use a 19-gauge EUS needle to puncture into the excluded stomach. And then we want to distend that stomach. We inject a lot of fluid, sometimes up to 500 mLs or even more, to really distend it out and create a nice landing zone or a nice runway for our catheter of our lumen-opposing metal stent. If you have a particularly active GI tract, you can sometimes give glucagon, which is what we do a lot of times when we're doing a gastroenterostomy. But this may not always necessarily be needed for the edge to create a gastrogastric fistula. In 2024 now, the predominant technique is to use a freehand placement of a 20-millimeter electrocauterine-enhanced stent, and then we can dilate the stent. And based on the data, most people will dilate anywhere from 12 up to 20 millimeters. And then you have to decide if you're going to do a same-session ERCP or if you're going to do a staged ERCP. If you're going to do a same-session ERCP, you need to consider stent fixation either via the use of endoscopic suturing or an over-the-scope clip to be able to reduce the risk of stent dislodgement or migration. If you're going to do a staged ERCP, then stent fixation is not necessary. You can allow that tract to mature over the span of a few weeks and then bring the patient back to be able to perform the ERCP at a later date. Once all of the ERCP sessions are complete, you want to remove the lambs and then think about fistula closure. So some people just leave the fistula for spontaneous closure. Others, including in my practice, we're a little bit more aggressive about active closure, and that can include using either monotherapy or combination therapy of argon plasma coagulation APC, over-the-scope clips, or endoscopic suturing. So I want to show a case now of a single-session EDGE. So this was a gentleman who had a Roux-en-Y gastric bypass. He was admitted with severe abdominal pain and found to have biliary pancreatitis. His LFTs were notable for significantly elevated total bilirubin of 4.2 as well as an elevated alkaline phosphatase, and he needed a cholecystectomy. But because of the severity of his pancreatitis, the surgery team did not want to take him right away for a concurrent cholecystectomy, in which case we could have done a lap-assisted ERCP. So after discussion with the patient and with surgery, the decision was made to pursue a single-session EDGE. So for this procedure, there are some similarities but also some differences compared to the prior staged EDGE that I showed previously. So first, again, accessing the excluded stomach using the EUS needle, putting in a lot of fluid to really distend the excluded stomach. Here you can see that on fluoroscopy with contrast. And then once we have a nice runway, we're going to use the 20-millimeter aluminum-opposing metal stent, freehand accessing the excluded stomach, and then deployment of the stent. So you can see the distal flange being deployed there. We pull back to have a nice tenting, creating a football shape and good apposition of the excluded stomach to, in this case, the jejunum, and then deploy the proximal flange. And you can see the stent there both on EUS and endoscopic views. So for single-stage EDGE, the next step after LAMS deployment will be to dilate the stent. So we're going to use a controlled radial expansion balloon across the diameter of the stent, open it up so we can then nicely see the excluded stomach. And then before we do the ERCP, we need to fixate the stent to reduce the risk of dislodgement or migration. So this is sped up, but this is the over-the-scope suturing using the Apollo overstitch. This is a 2-0 polypropylene suture that's used to fixate the stent to the GI tract wall. There's the cinch catheter that's used. And then a second suture is placed on the opposite side. And now we can gently advance a duodenoscope on this index session through the aluminum-opposing metal stent into the excluded stomach, and then advance it all the way down into the duodenum to the second portion of the duodenum where the ampulla lies. Now we can go back to our conventional ERCP method. So we cannulate the bile duct, we can do a cholangiogram, and then here use an extraction balloon to eradicate the stones that we're obstructing. Once we've finished our ERCP, in this case, because the surgeons wanted to wait a little bit before the cholecystectomy, a biliary stent was prophylactically placed. That patient then underwent a cholecystectomy a few months later, and then they came back to us for their final endoscopic procedure. So we, again, went down with a duodenoscope, went to the biliary stent, which we removed, did a final clearance of the bile duct with a balloon, and demonstrated that there was no other residual stones left in the bile duct. So now it was time to remove the lambs. And so we cut the sutures using endoscopic scissors, and then used forceps to grab and remove the lumen-opposing metal stent. So here's what the jejunogastric fistula looks like. And in our practice, we perform closures. So what we want to do is first sort of devitalize or deepithelialize the mature tract using APC, which helps to promote scarring and fibrosis. And this is a little bit of a higher wattage than what we're typically accustomed to. It can be anywhere from 50 to 70 watts, and flow rate of 0.8 to 1 liter per minute. And then, again, this suturing part is sped up, but we use a purse-string technique to be able to suture down, in this case, the jejunogastric fistula to try to reduce the risk of a persistent fistula in this patient. So we take multiple bites in a purse-string fashion, and then we drop the suture anchor, and then advance a cinch catheter, tighten down the suture, and then deploy the cinch and cut the residual slack. So once that's done, then, we can go back with a regular forward-viewing scope, examine the site of where the fistula previously was, inject contrast under fluoroscopy, and as you can see, you just see filling of the jejunal limb. There's no filling of the excluded stomach. And then, about eight weeks later, we can do a confirmation of more durable closure with an upper GI series that, again, just demonstrates filling of the small bowel and nothing going into the excluded stomach. So that's an example of single-session EDGE. And so some tips now, if you're thinking about incorporating EDGE into your practice, or if you're just early on in the learning curve, what do you need to know about EDGE? So when we perform EDGE, we typically want to do this always under general anesthesia. You want the airway to be protected, because when you deploy the stent, there oftentimes will be a lot of reflux of the fluid that you placed into the excluded stomach that can reflux back into the pouch, and you don't want that patient to aspirate. I find that the left lateral decubitus position is a good position for having nice apposition of the excluded stomach to the gastric pouch. With any therapeutic EUS procedure, you want to be using carbon dioxide. If there happens to be an adverse event, like a perforation, carbon dioxide is absorbed much more rapidly than air is. In terms of access, we prefer gastrogastric fistula creation over jejunogastric because there's a lower risk of stent dislodgement when you go stomach-to-stomach versus small bowel-into-stomach. And then I would say it's helpful, but not necessary, to use fluoroscopy for EDGE now. However, I would always perform it in a fluoroscopy-capable room in case you have an issue with stent misdeployment or you need to salvage or place a bridging stent. It's always better to be in a room that has fluoroscopic capabilities. So what are the benefits of EDGE? It really has been a game-changer for Roux-en-Y gastric bypass patients who need an ERCP. They're able to avoid surgery for the most part unless they need a concurrent cholecystectomy. They don't have to deal with percutaneous access and dealing with a drain that can be very cumbersome and irritating. It can get caught on their clothes, there can be leaks, and then they get a lot of staining on their dressings or clothes. Percutaneous drains may need to be changed or upsized so they can avoid all of that. If you need to, you can go back in and do a repeat intervention using EDGE. As compared with laparoscopy-assisted ERCP, it eliminates the need for maintenance of a PEG tube for gastrocutaneous fistula tract maturation. And EDGE certainly has shorter procedure time and length of stay when compared to laparoscopy-assisted ERCP. And then one of the nice things for us as endoscopists is we can do this entirely in the endoscopy suite. We don't have to take a road trip to the OR where we're a little bit out of our element and don't necessarily have all of our supplies readily accessible to us. And EDGE has very, very high rates of both technical and clinical success. So let's review some of the long-term results for EDGE, and this was a study that was published last year. It was incorporating 172 patients across 10 centers. The majority of cases, a gastro-gastric fistula was performed from the pouch into the excluded stomach. And the majority of practitioners in the study used a 20-millimeter electrocautery-enhanced lumen-opposing metal stent. Most of it was freehand, but 25% was wire-assisted, which is where after you distend the excluded stomach, you place a wire through the needle and leave that in the excluded stomach. And then over the guide wire, you perform a lumen-opposing metal stent placement. The LAMs that was most commonly used was the 20-millimeter diameter LAMs, which actually has a 78% increase in surface area when compared with the 15-millimeter LAMs. So it's probably less likely that you'll have a dislodgement of the stent using the bigger size compared to the smaller one. And in this study, practitioners dilated the stent about 86% of the time. Again, the range was about 12 to 20 millimeters in diameter with a controlled radial expansion balloon. And then finally, stent fixation was performed in about 19% of cases. You can see that the main procedure time wasn't that bad. It was a little bit more than an hour and very high rates of technical success at 99% and clinical success at 95%. So what about some of the downsides of the adverse events? Probably the biggest adverse event that was seen was stent migration or dislodgement. That was in about 16% of cases, followed by bleeding at 6%, ulceration and pancreatitis at 2% each. The mean indwelling stent time for the lumen-opposing metal stent was 69 days. And as we think about the evolution of EDGE over the last decade, probably the two biggest questions that come up with respect to long-term results are the presence of a persistent fistula and whether that patient is going to be gaining weight in the long-term. So with respect to fistula, after LAMS removal in the study, it was about 50-50 in terms of whether the fistula was actively closed at time of removal or whether it was left to spontaneously close. And we can see a persistent fistula in about 31% of EDGE cases. And what we found is that it correlated with the indwell time of the stent. So those patients that had persistence of a fistula, the stent was left in for a much longer period of time, closer to 90 days or three months versus just 50 days in those patients that did not have a chronic persistent fistula that developed. The good news is that in patients that did have a persistent fistula, if they underwent endoscopic attempts at closure, that technical success rate was 100%. So with respect to fistula closure, we want to think about generally earlier removal is better to reduce the risk of a chronic or persistent fistula. With weight regain, we saw weight regain in about 36% of patients, and on average it was about 12 pounds. There are some challenges and limitations, I would say, of EDGE. With respect to therapeutic EUS, it does require someone that has really high-end expertise with therapeutic EUS and you have to feel comfortable identifying the excluded stomach, accessing it with a needle, being able to distend it, and then feel comfortable with placement of lumen-opposing metal stents. A caveat about particularly challenging anatomy, there are a number of patients that will have failed sleeve gastrectomy as their initial bariatric surgery that then get converted to a rune-wide gastric anatomy. And we have to be careful because of that staple line along the greater curvature, there may be poor expansion of the excluded stomach which may limit the sort of landing zone that we have for our lamb's catheter when we do our fluid injection. So understand if they are just native gastric bypass anatomy or if they've been sleeve converted to rue anatomy because there might be reduced expansion of the excluded stomach in that latter patient population. So does EDGE have the edge when compared with lap-assisted or enteroscopy-assisted ERCP? A study that was published earlier this year examined that. It was a network meta-analysis that included 16 studies and what they found was that technical success was not significantly different between EDGE and lap-assisted ERCP. Both had much higher success rates than enteroscopy-assisted ERCP which I mentioned earlier was only in the 60 to 70 percent success range. Adverse events overall were pretty similar and EDGE was able to be performed significantly faster than either lap-assisted or enteroscopy-assisted ERCP. So they recommended EDGE as first-line therapy if expertise was available. What about a cost perspective? So this study was a cost-effective analysis looking at those three modalities for ERCP after rune-wide gastric bypass surgery. They had a decision tree model with a one-year time horizon and they used Monte Carlo simulations to assess incremental cost-effectiveness ratios, net monetary benefit calculations, and a cost-effectiveness acceptability curve. What they found was that EDGE had the lowest total cost and the highest total quality-adjusted life years or QALYs for a total of $5,188 per QALY. So what they ultimately found was that EDGE was the most cost-effective modality for ERCP and post rune-wide gastric bypass anatomy. And intuitively this just makes sense, right? You're doing this in the endoscopy unit so it's going to be significantly cheaper than doing this in the operating room and when you factor in the low success rates of enteroscopy assisted ERCP and additional interventions required for that patient population, EDGE, which can be done in a single stage or multiple stages with very high success rates, is going to be more cost-effective. There has been some evolution of EDGE so when we initially described EDGE it really was to facilitate just an ERCP in this bypass anatomy. However, there were alternative terms that have since been described such as gastric access temporary for endoscopy or GATE as well as EUS-directed transgastric intervention or EDGE. And this is just expanding upon the fact that patients with this anatomy may need other endoscopic procedures in that same foregut area that may not necessarily be an ERCP. So for example, it's been described to use that same idea of lumen apposition between the gastric pouch and the excluded stomach to be able to perform an upper endoscopy to sample a mass there or to close a duodenal ulcer perforation. In addition, an endoscopic ultrasound can be passed through a lumen opposing metal stent to sample a pancreatic mass or to drain a pancreatic fluid collection or perform diagnostic evaluation of the biliary tree. So we can expand upon the early concepts of EDGE of creating that bridge to the excluded stomach to not only perform ERCP but other endoscopic procedures as well. So here's my management algorithm. The factors to consider when you're thinking about what approach you're going to take is what's the post-surgical anatomy. If you have access to the operative report that's very helpful to know the length of the root limb and the biliopancreatic limb. You need to know about the available expertise not only for the endoscopist but also the team that you have there, making sure that you have appropriate equipment and especially early on ensuring that you have surgical backup should there be any mishap that can't be managed endoscopically. If a patient needs a concurrent cholecystectomy, that's where laparoscopy-assisted ERCP has the most benefit. If they have cholangitis or are very symptomatic, single-session EDGE, so performing the ERCP in the same index session where you place the limbs, can be very helpful but remember to fixate the stent to reduce the risk of stent dislodgement or migration. If they have a very short root limb, that's where you can consider enteroscopy-assisted ERCP. However, in my practice, if surgery is not required, I really prefer the EDGE but I do aim to remove the limbs as soon as possible. I would say the the shortest amount of time would be four weeks because you need that track to mature where you created the fistula but if you can get it out anytime after that, then that may help reduce the risk of weight gain and persistent fistula formation in these patients. So here's an example of an algorithm that we algorithm that we use for ERCP and rheumatoid gastric bypass patients. If they require a cholecystectomy concurrently, then go to the OR with the surgeons. Think about do they need a repeat procedure. If so, EDGE definitely has the benefit and if you have access to the op record and you know that there's a short limb and a short biliopancreatic limb, then you can consider enteroscopy-assisted ERCP, although in our practice we still favor EDGE in that scenario. So EDGE has really changed the landscape for pancreatic biliary intervention in rheumatoid gastric bypass patients but there still is room, I think, for refinement and optimization. So a couple of questions that always come up is what's the optimal LAMs indwell time? We don't yet know the answer but we think the shorter the better. Again, you know, removal ideally after four weeks when all of the ERCP interventions are complete. Should single session EDGE be preferred to stage EDGE? Again, that correlates directly with the LAMs indwell time. I think some practitioners have shifted to this because they're comfortable with stent fixation and have been able to really reduce the risk of stent dislodgement with the methods of fixation that we have available. And then should the fistula be closed endoscopy at the time of LAMs removal and by what method? There is some variability here. Half people close it and half leave it for spontaneous closure. In our practice we like to typically perform active closure with APC and endoscopic suturing. So here are the final slide on take-home points. We know that biliary complications can occur in the post-bariatric surgery cohort. ERCP and other procedures like endoscopy of the excluded stomach or EUS for sampling of a pancreatic head mass are needed the post-bariatric surgery patient population. For sleeve gastrectomy anatomy, thankfully we can just do a conventional ERCP. We just have to be mindful that our scope may be in a little bit more of an unstable position because of the excision of the stomach along the greater curvature. For post-ruin-wide gastric bypass patients, the options for ERCP include EDGE versus LAP-assisted versus endoscopy-assisted, but EDGE really is minimally invasive. It's safe, effective, faster than LAP-assisted or endoscopy-assisted, and it utilizes less resources from a cost perspective. If a patient has cholangitis or is really symptomatic, think about single-session EDGE with fixation of the stent. Remember to try to remove the lumen-imposing metal stent as soon as possible after four weeks if you've completed all of the ERCP sessions to help reduce the risk of persistent fistula formation and weight gain. We recommend EDGE as first-line therapy if expertise is available unless a concurrent cholecystectomy is needed. With that, I'm happy to stop and answer any questions that Manik, you may have or that the audience may have. Yes. Thank you, Dr. Kumta. That really was a tour de force review of this clinically very relevant problem that we see on quite a regular basis in practice. As a reminder to our audience, please submit any questions that you have through the Q&A icon and not through the chat button, and feel free to chime in and ask any questions. Dr. Kumta has a wealth of experience in this field, and his insight is very valuable to all of us. I'm just going to quickly look here. So one question that I had, and this is for someone who's getting into advanced endoscopy, is what advice would you give trainees and early career faculties who are doing this in terms of pre-procedure planning to be successful in doing an EDGE or doing ERCP in patients with pediatric surgery? Yeah, that's a great question regarding pre-procedure planning. So I think there's a lot of considerations that come into play here. The first and foremost, I think, is patient selection. So you really need to understand and assess the patient's anatomy, make sure that you have a good clinical indication for performing the procedure, and making sure that the patient overall is an acceptable or appropriate candidate for endoscopy to undergo this procedure. The next thing I would say is ensuring that you have pre-procedural cross-sectional imaging, either a CT or an MRI, to help define the area of concern, to give you a roadmap for ERSP, like you would with any standard ERCP case. And then I think, especially early on in training, multidisciplinary collaboration is really important. So as you saw with the single-stage EDGE case, I think discussion with surgery is really paramount. Discussion with the patient in terms of understanding really informed consents of what the risk benefits and alternatives are to EDGE so they understand what they're getting themselves into is of critical importance. And then finally, I think that EDGE builds on the foundation of therapeutic EUS. So for trainees, it's really important to focus on the finer details of diagnostic EUS, of understanding planes, understanding that small movements with your shoulders or with your right hand on the insertion tube can make a world of a difference in EUS, certainly compared to conventional upper endoscopy or colonoscopy. And then building on the techniques of, for example, utilization of LAMs. So getting comfortable with LAMs deployment in more traditional settings, such as pancreatic fluid collections or cholecystitis, those are two on-label indications for use of lumen-opposing metal stents. And so this procedure, it really comes upon the building blocks of the foundations of therapeutic EUS, and it's a nice way to link therapeutic EUS and ERCP. That well said. I agree about your point that it's very important as to to be sure the need for the procedure and the real need for informed consent in these situations. One of the questions that one of our audience members had was, in terms of stent fixation, is there a role for XTAC for both fixation and fistula closure if full thickness suturing is not available? Yeah, that's a good question. So I think in terms of stent fixation, if you think about sort of broadly what's in our toolbox, we have through the scope clips, I don't find them to be very effective because they're quite superficial. Then you have over-the-scope clips, so those come in two varieties. You have the the bear claw type clip, so that's the Ovesco clip, and then you have the padlock type clip, which is the Aponos clip. Those, and Ovesco has a stent fix type of device that's specifically designed, you know, for stent fixation. So those over-the-scope clips are an alternative for use for stent fixation. I probably would do two points of fixation if you're going to do single stage edge, and then you have endoscopic suturing. So my preference is the over-the-scope suturing. I think you have really good ability to fixate the stent to be able to tolerate some, you know, some wear and tear from the duotoscope going through until you can get into a more stable position for your ERCP. Once you're in a stable ERCP position, the stent isn't really moving all that much. But if you don't have access to that, then X-TAC can be a consideration. However, a couple things to keep in mind. The TAC itself only has a length of about three, three and a half millimeters or so, and it's a barbed metal TAC. So my warrior concern, I haven't actually used it in this in this particular setting, although I know it has been used, is that you're going to have the metal TAC and the metal of the stent kind of get embedded together. It's also not full thickness. The X-TAC helical TAC is laser cut, and there's an eyelet that stops it at about three, three and a half millimeters. So at best in thick-walled luminal structures, you're really going to be submucosal and maybe intramuscular. But I think if you don't have any other options, this may be potentially an option to use to try to fixate the stent, but it would not be my first fixation method of choice. Good point. In terms of the stent removal, I know you touched this briefly in your presentation about the longer duration of stent indwelling time kind of being related to fistula. Has your practice changed afterwards in terms of how long you keep the stent in? Is there a push for more early removal of stents? I know there was a little talk about same session and promoting more of that, but if somebody were to start removing the stents earlier, is there data on that or it's aware of something? Yes, we don't have a ton of data on this, but the general takeaway, as I mentioned in the talk, is that the longer the stent indwell time, the higher the risk of persistent or chronic fistula. So there is now a move to try to get these stents out sooner. How soon, we don't exactly know, but I think that certain centers are pushing more for single session ERCP as part of the index placement of the lambs, because then you can, you don't have to wait that two, three weeks or so to allow for maturation of the fistula, and you can cut down on the stent indwell time if you fixate the stent and perform a single session edge. So again, I think the general takeaway is to try to keep the stent in place only for as long as needed, try to keep it in as minimally short indwell time as possible, and then remove it as soon as possible to try to minimize the risks of chronic fistula and weight regain. Do you use devices to closure in single session edge as well? Yeah, so the single session edge, you actually still have to maintain the lumen opposing metal stent. You don't want to take the stent out right away necessarily with a immature track, unless you're 100% sure that you don't need to, you may not need to go back in at a later date. So typically you can preserve the track for at least four weeks to allow for maturation, and then pull the stent out. My practice is to perform active closure. So I like to denude or de-epithelialize the mucosa with APC, and then utilize ovoscope suturing in a purse string pattern for durable closure. I find that if you wait and allow for spontaneous closure, going back in at a later date, again, because of the, you know, the official nature of epithelialization, it becomes harder to manage endoscopy the more chronic fistula has been present. I think we have time for one last question as we're hitting the hour mark. One of our audience members had a question about preference of over single use duodenoscope versus reusable duodenoscope. Yeah, it's a good question. So in this setting, I think the benefit of the single use scopes is when you're doing a laparoscopic assisted ERCP, because then you don't have to worry about sterility. You can use the scope once and then, you know, dispose of it appropriately afterwards. With more standard edge, you can use a conventional duodenoscope. There are some thinner duodenoscopes that are available as well, so that you won't have as much friction between the scope and the lumen-opposing metal stent. But for the most part, we use conventional ERCP scopes for the ERCP portion of the edge procedure. Thank you so much. Again, we're at the hour mark and Dr. Kumta, thank you for this wonderful talk and for our audience for joining in and listening to our webinar today. We hope that you found the information helpful to you and your practice and is clinically usable very soon. As a reminder, you can access the recording of this webinar by logging on to GILeap by going to learn.asge.org. Please also save the date for ABE's next educational event, the 2025 annual course, which will be held at DDW on Friday, May the 2nd, 2025 in sunny San Diego, California. The hands-on course at DDW will now be on a Tuesday, May 6th, 2025, which has historically been at the ASGE Learning Center on Sundays of DDW, but from now on will be held on Tuesday afternoon in 2025. If there are no more questions, thank you again for your participation. This now concludes our webinar. Please have a great evening and good night. you

ERCP

bariatric surgery

Roux-en-Y gastric bypass

minimally invasive

EDGE procedure

enteroscopy-assisted ERCP

laparoscopy-assisted ERCP

stent migration

advanced endoscopy