So, we heard a lot about lumen-opposing metal stent, lumen-opposing metal stent, and we're going to talk more about lumen-opposing metal stent. So, this is a case I saw last year, 61, presented to a clinic for evaluation of intermittent right upper quadrant pain, nausea, vomiting, significant past medical history, surgical history, as you can see, he had a Roux-en-Y gastric bypass for his obesity, history of bowel perforation, extensive resection for that, complicated by Shotgut syndrome, he had a history of urethelial cancer, he underwent chemotherapy, surgery for it, medical problems like rheumatoid arthritis, CKD. So, nutshell, really not a great protoplasm. So, and this is, okay, and to investigate his symptoms further he gets a CT scan, who would want to comment on this? Obviously, this is an axial image, non-contrast. Intra-hepatic ductal dilation, common bile duct dilated, multiple large gallstones, and choledocholothiasis, yes. So, multiple gallbladder stones, the largest was about three centimeter in size, and he had about two or three common bile duct stones. Okay, so this is the same, I'll skip the coronal, basically it shows the same thing, CBD stones, multiple large gallstones. So, what would you do next? Somebody said EOS guided gallbladder drainage? Can you speak in the microphone, please? Gallbladder drainage would be a potential option. Okay, in a patient with Rheumatoid Gastric Bypass? We can go in, take a look, if we get a good angle, either the gallbladder drainage or drain the bile duct directly. Or you can do edge. That would be the problem, you know, with this gastric bypass, if the pouch is not, or the edge procedure would be a way to go. Edge procedure. I think you can also, on top of edge, you can consider, based on your institutional specialty, you can do a device-assisted enteroscopy, or if the patient may need surgery, like a lap assist, I mean, that's just an option. Okay. Okay. So, I heard balloon, which will take care of the bile duct stones, not the gallbladder stones. So, puts a patient at risk for recurrence. Recurrence is very high, with large three-centimeter stone. Patient is at risk for meritses, recurrent acute cholecystitis, plus gallbladder cancer. So, stone larger than three centimeters stone, recurrent acute cholecystitis, plus gallbladder cancer. So, stone larger than three centimeters size in gallbladder, there are indications of a prophylactic cholecystectomy in those patients. So, this is a patient who's not a surgical candidate. You have to tackle both the gallbladder issues and the bile duct. And some of the procedures that we mentioned, they tackle bile duct, but they may or may not tackle the gallbladder. So, what would faculty do? So, this is a patient who has experienced surgeons and felt frozen abdomen, not a surgical candidate. All right, so several options were discussed, again, all valid options. Don't forget, there is another technique we can utilize our IR colleagues. This is something we published, hybrid percutaneous endoscopic removal of large gallstones. So basically, in this case, the patient probably would end up two tubes. The patient, most of the times at outside hospital, they have a cholecystostomy tube, and they may need another tube through their common bile duct if the IR people are not able to cannulate the cystic duct and get the wire down and push the stones out that way. But once you have the gallbladder accessed percutaneously, you can use the existing tract. Usually we let this tract mature. So it takes about four or five weeks for the tract to mature. Once the tract is mature, it's gradually upsized to about 16 French or 18 French in size. And then you can go and remove the tube out. You're working with your IR colleagues, or you can work this on your own. Remove the tube out over the guide wire. And over the guide wire, you can advance the dilating balloon. This is a, you know, even we are not supposed to be using the brand names, but the balloons that are available from the traditional device companies that are in endosuites that don't work that well in distending the abdominal wall. So this is the balloon that we get from IR. It has a higher burst pressure. And we distend the percutaneous tract 16 to 18 millimeter. And once the tract is distended, you can use the fully covered self-expandable metal stent, 6 or 8 millimeter in length based on how much of the abdominal fat is. So now you have one end of the fully covered stent in the gallbladder. Second end is exiting out from the belly. You can drive a standard upper scope, even one T-scope through it, and then clear the gallbladder out. And in this case, as you see, wire is going down from the cystic duct out into the duodenum, and you can clear the bile duct out. So if you have a situation where you have a percutaneous strain, you can utilize this for that procedure. And some of the options are listed here that you can use. Lap-assisted ERCP was mentioned. This patient is not a surgical candidate. Of course, EDGE was mentioned, balloon. And don't forget, 7% to 10%, 10% is a generous number, these patients can have a chronic gastrogastric fistula. So if you're contemplating an EDGE procedure, I always start, I'm sure a lot of my colleagues do, start with an upper scope to look for a chronic GGF. Utilize that fistula. You can dilate it and go on to do your procedures. So how do these procedures compare, EDGE versus balloon versus lap-assisted ERCP? When it comes to technical success, balloon carries the least in terms of success. Not a surprise. It's difficult to reach, especially in obese patients. It's a rather long limbs. And once you get there, the more tricky part is actually cannulating, just because we don't have accessories that are compatible and the position of the papilla. Adverse events, they are quite comparable. Cost-effectiveness, believe it or not, despite taking into account $5,500 cost of a LAMPS, EDGE is more cost-effective. And the reason is because of the length of stay in the hospital. EDGE procedures, generally outpatient length of stay is about a day compared to lap-assisted ERCP, where the average length of stay is up to 3 1⁄2 to 4 days. I mentioned about the gastrogastric fistula, again, not uncommon. Look for it and utilize the tract. So most of us, you know, we use the freehand technique. This is how I do my EDGEs. Most of my colleagues who are sitting here in the panel here today, they also, I'm sure, they use a similar technique. You go in, and this is what the gastric pout, the remnant will look like. Todd described this, Todd Barron described this as a sand dollar sign, a really apt description. Once you localize it, 19-gauge needle, and it's a concoction that we use, which is water or saline mixed with contrast and methylene blue. You attach this directly to the pump, and you're standing on a foot pedal. You're not using the syringes. I think that's much more cumbersome and hard on your techs. Usually need about 250 to up to 300, 400 cc to distend the stomach. You want the remnant distended minimum of two and a half to three centimeter. And then you can go with a 15-millimeter or 20-millimeter diameter cadre-enhanced lumen-opposing metal stent. This is a freehand technique. You go directly in without the wire, deploy the phalanges under EUS guidance. And then once you see the methylene blue coming out on the other end, you know that you have done a proper job. Now, the burning questions that come in with the edges are, should we do one-step or two-step? Should we be concerned about persistent fistula weight gain? Because those are the questions that we get from the surgeons. And what about the adverse events? And what role does using a 15-millimeter, 20-millimeter lamps and the excess site going from the pouch versus going from the rule lamp, do they have any impact on these parameters? I do my edges all two steps. The data on one step, if you were to do one step, it has to be emergent indications. Patient is cholangitic. Patient has a bile leak without any JP drains. There are risks for bile peritonitis. Those are the ones you want to go in urgently. But in my humble opinion, getting a PERC drain in those patients is absolutely OK. You can then bring them back electively and go on to take care of the stones, et cetera, that you need to. So the data on one-step edge came from this large multi-center retrospective study, 128 patients. Brianna Shin, who's at Jefferson, published this data. Notice out of 128, 11 lamps migrated. So migration rate was about 8.6%, so not a trivial number. And they found in this study that 20-millimeter lamps, if you use 20, and if you suture risk, the risk of migration was less, not zero. It's less. And the outcome was, if you want to do one step, use 20 and suture it. Another study, which they had an interesting twist to this one step, is short study, 11 patients in single session and another 11 in what they called as shortened interval, where they brought the patient back two to four days later. So when we do two-step, we bring them back two to four weeks later. So what they did was, instead of waiting two to four weeks, they brought them two to four days later. And despite the shortened interval they found, the ones that they brought two to four days later, they had significantly fewer migration. Now, both the groups, they had 20-millimeter lamps. None of them were secured. Technical success was higher in the shortened interval. And then adverse events, of course, were much lower. So they suggested the compromise could be, instead of same day, you can bring them back two to four days later. Now what about persistent fistula? In this slide, we have over 300 patients here, including the largest study from one Kashab, 178 patients that our center was part of. Bottom line, take-home point from this slide, persistent fistula, in these studies where they looked for persistent fistula, they found up to 0% to 12.5%. And of those, in that largest study, 178, majority of those, they were brought back and they were able to close the fistula. Was there any weight gain in these 350 patients? No, there was no weight gain. If you notice, the challenges have been there are multiple methods that are used for fistula closures, APC, ovesco, suture, mucosal denudation. So there is no standardized process on how do we close this fistula. I personally do mucosal denudation. I really burn the fistula tract with APC. And if I anticipate patient may need ERCP down the road, I leave a seven French double pigtail stand across the fistula, which also facilitates the closure. I bring them back for an upper GI at six weeks. So studies have shown what are the factors associated with persistent fistula. If you leave the lambs in longer, so if it's been there for more than 35 days, chances of fistula will be there. Patient with underlying diabetes, if you are using 20 millimeter lambs, and if you choose a primary method of closure without mucosal denudation, the fistula is more likely to stay open. What the studies didn't show was the access site. Going from the pouch versus RULIM. That being said, in my personal experience, I've noticed RULIM closes more predictably than going from the pouch, because sometimes when you're going from pouch, you're closer to the staple line, and that's the risk of ischemia, suture, staple line, resection line, and the risk of fistula is higher. So I intentionally always try to go from RULIM. Adverse events. Of course, everybody is aware the dreaded mal-deployment of the stent, which can lead to perforation, pneumoperitoneum. It can happen during. It can happen after. And then bleeding. So I think this is one of my cases, actually one of the early on cases, where I was live recording this, and I had the video recording team in the unit. I had done the step one, the access site from the blind limb, and I go down to do the step two. Stent was nowhere to be seen. At some point with me doing the step one and bringing the patient back, the stent had migrated out, and we did the fluoro. The stent was sitting in the remnant stomach, and at the access site, you can see this tiny pinpoint opening. Now once I see the opening, to me, this showed that the stent had been there for some time, and I was pretty comfortable. The access site or the fistula, it was deceased. That's why I was comfortable putting a wire through it, going into the remnant stomach, going with the balloon over the wire, injecting contrast, conforming it, and then balloon dilating the tract, and finally putting in through the scope fully covered metal stent, dilating the stent, and then go about doing the ERCP. This was a case of divism. So take on point, you will encounter these unexpected scenarios. Make sure your toolkit is stocked. You know, you have these longer wires. You have fully covered metal stents, et cetera. You have closure devices to salvage the situation. Another thing that we encounter unexpectedly, especially if you are going from the rule M is this hockey sticking of the scope, especially older pouches, which are bigger pouches. Your scopes start looping. We reported this novel use of Overtube. It has really helped me out in a couple of situations where it's rather disappointing you do a step one, and then you're unable to do step two because you're not able to advance the scope through the lamps. So use the Overtube. It's a 50-millimeter long, 19-millimeter inner diameter, and it can help straighten the scope to prevent the looping. Sometimes I have removed the lamps out. That has also helped me do EUSs especially. Okay, so I'm going to skip the GJ. So since this case was about the gallstones and possible edge, just a couple of slides over endoscopic management of gallbladder. And I think this is one of my favorite sites, which shows just a timeline of how things have evolved from open coli from 1888 when the trans-papillary drainage came in, EUS-guided gallbladder drainage in 2007 by my mentors Todd Barron and Mark Topazian. I was an advanced fellow at that time. And then, of course, EUS-guided lamps has been around since 2011. So this is, even though we are talking about it now, we've been doing this for more than 15 years. Everybody, if you're not aware of Tokyo Guidelines, make yourself aware. One of the wins of Tokyo Guidelines 2018 was that EUS-guided gallbladder drainage was added as an acceptable option in high surgical risk patients. And then why? Why do we do this? What are the advantages? Easy, internal drainage, it's physiologic drainage of bile. You can remove stones, as Tarun mentioned. Several disadvantages. The disadvantage list is a little bit higher. You know, you're targeting mobile structure from another patient, need anesthesia, lack of standardized tools and techniques, stent issues, long-term. If patients, they become surgical candidate down the road, surgeons, they will call you and say, well, that was tricky because there's still a duodenal fistula, food clogging issues, and we don't know the long-term implications. I think the indications for gallbladder drainage is expanding. We started with high surgical risk, but just as I showed you this case, patients with altered anatomy, common bile duct stones, gallstones, yes, biliary pancreatitis, of course, you can offer these. There are several choices available in global market, but we don't have very many of these options available to us. Gallbladder drainage, again, very similar to any other procedure where we use lamps. It's, again, freehand deployment. I personally try to go from the duodenum, unless we think the patient will become a surgical candidate. Again, you go from the stomach because stomach fistula site is more predictable. Lamps, migration, tumor, ingrowth, et cetera, is higher if you go from the antrum. You need to be as close as possible to the gallbladder. Again, distance, keep it less than centimeter, although we have saddle-length lamps that you can use for higher. You notice this gallbladder is full of this starry sky appearance. That's all the sludge you see in the gallbladder. Look for the wall integrity. Look for blood vessels. Be careful if somebody has perforated gallbladder on imaging or gangrenous gallbladder or have had recent chemotherapy and radiation. Those walls, they fall apart like anything, so you have to be very careful in judging the integrity of the wall on EOS before you go on to do the drainage. Again, it's all freehand without the wire under EOS guidance, and then once it's deployed, you see a nice gush of bile, pus, and stones coming out and the stent popping up. What is the data? Busy slide. A lot of retrospective studies, including the one highlighted, we were part of. High success rate, technical, clinical complications, most of them are migration and food impaction. This is the study that actually changed the landscape. This was an RCT published by Tony Teo looking at percutaneous versus endoscopic ultrasound-guided gallbladder drainage. Again, one-year adverse event, 30-day reintervention, readmissions, recurrent cholecystitis were significantly lower in U.S.-guided gallbladder group, and technical success, clinical success was comparable. Well, that group pushed the envelope a little bit further, and they published this study in GIE, which was a propensity score analysis where they had the patient allocated to average surgical risk, not high surgical risk, so all comers to EOS group and then the lab co-lead, and again, the data was comparable, technical success, clinical success, hospital-stay adverse event, recurrent biliary events, cholecystitis, et cetera, so I think once it's become mainstream for high surgical risk, will we be offering this to the average surgical risk? I think so, yes. I'll skip this in the interest of time, and so going back to our patient, what did we do? Of course, we are all advanced endoscopists here and like our tools, so we did the edge. Again, I intentionally go through the root limb, and you notice going down into the remnant stomach, brought the patient back, did ERCP, removed the docholithiasis, did the same session, EOS guided gallbladder drainage, and then brought the patient back for direct cholecystoscopy and direct electrohydraulic lithotripsy. We broke all the gallstones, cleared the stones out, and removed both the lambs out. The patient is on ursodial, so that's all I have. Thank you.

lumen-opposing metal stent

gallbladder and bile duct stones

surgical candidate

right upper quadrant pain

endoscopic-guided gallbladder drainage

fully covered self-expandable metal stent