Hello, everyone, and welcome to this webinar on endoscopic management of chronic sleeve and gastric bypass fistula, presented by the Association for Bariatric Endoscopy. My name is Marty Roth, and I will be your moderator for this program. Before we get started, there are a few housekeeping items. There will be a question and answer session at the close of the presentation. Questions can be submitted at any time online by clicking the Q&A feature at the bottom of your screen. Once you click on that feature, you can type your question and hit return to submit the message. At the conclusion of this webinar, we ask you to take a brief survey located in the networking lounge. The survey will take less than a minute to complete. Also, please note that this learning event is being recorded and will be posted in GILeap, ASGE's learning management platform. You will have ongoing access to the recording in GILeap as part of your registration. Our presenter for this webinar is Dr. Diogo Moura. Dr. Moura is an associate professor in the gastroenterology department at the University of Sao Paulo and faculty at Medicine Cliniques Hospital in Sao Paulo, Brazil. He did his postdoctoral research fellowship at Brigham and Women's Hospital at Harvard Medical School in Boston. And finally, he is currently the president of the Young Endoscopist Group for SOBID, which is the Brazilian Society for Bariatric Endoscopy. At this time, I would like to turn the presentation over to Dr. Diogo Moura. Hello. So, first, I want to thank you, ASGE and ABE, for this invitation. It's a pleasure to present this talk. We're going to discuss endoscopic management of chronic sleeve and gastric bypass sclerosis, and we're also going to talk about the treatment of acute endury needs. I have enough at your disclosure related to this talk. So, as everyone knows, bariatric surgery is the most effective treatment for obesity and associated comorbidities. However, adverse events can occur, such as fistulas and leaks. And the rates of fistulas and leaks varies between centers, so in high-volume centers with high experience, the rate is about 1 to 2%, but in other centers, it can go up to 6%. The mortality rates are low, but it can occur, so we really need to treat this patient, so the faster we treat this patient, the lower is the risk of mortality. These are some definitions. It's interesting because some people really doesn't know the difference between leaks and fistulas, and most people think that leaks are related to an acute and early defect, and fistulas are chronic defects. Usually fistula really occurs after untreated long-term leaks, but the definition is not like this. The definition for fistulas is an abnormal communication between two epithelial surfaces, and for leaks, it's the communication between the inter- and extraluminal compartments, and it often occurs in the suture line after surgery. So the cause of leaks and fistulas are multifactorial, so there are several factors which are related to this disease, such as inadequate vascularization, tension up on the suture line, staple failure, tissue fragility, and down-spin stenosis. So the location after bypassing sleeve leaks, usually after a sleeve leak, most of the defects are in the angle of this, so it's very important when you are performing an endoscopy, trying to find the defect, to follow the staple line, so when you follow the staple line, you're always going to see this leak, so it's very important to do that during endoscopy. And the location of gastric bypass, so there is this classification, and in most cases, when we need to treat by endoscopy, it's the type 1 and type 2, and sometimes the type 2, type 3. This is the most common location of chronic fistulas, so you have the gastrogastric fistula, the gastrocutaneous fistula, and you can also have the gastrorespiratory fistulas. When you have a gastrobronchial, usually it's transdiaphragmatic, and esophagus bronchial is usually transreactive, so it's very important to understand the anatomy before choosing the appropriate technique to treat this defect. So the treatment for chronic fistulas, usually this patient is stable, so when you have, for example, a chronic fistula, a gastrocutaneous fistula, so this patient, it's already drainage, so he drainage by himself, so the body treated the disease, and so this patient won't be in a very bad situation, like acute infection, things like that, which is more related to early leaks. So when you have an early leak, you need to treat in four steps, so the systemic treatment, so you need to give food to this patient, nutrition, antibiotics, and then you need to drain this patient. You can drain it by surgery or radiology, and now with the new endoscopic approach, you also can drainage by endoscopy, which is related to a very high rate of clinical success, and you also need to treat the factors related to the leak. So when you have a septum, you need to do the septotomy, when you have a downstream stenosis, you need to dilate this patient, and when you have foreign bodies, you need to remove these foreign bodies. So these are the basic steps for treating patients after complications, after bariatric surgery. And finally, when you treat this patient, this patient is in good condition, you're going to do the fistula repair, and usually we are treating this patient by endoscopy, but surgery is also an option. So the endoscopic treatment, this slide is the most important in my opinion of this presentation, so all the bariatric surgeons need to understand this slide. So when you treat an early leak or an early fistula, the rates of clinical success is very high. So you have some papers showing 100% clinical success, some papers showing more than 90%, so it's very, very important when you diagnose this patient, you need to send this patient to endoscopy, and because usually all surgeons, they used to try a nasolateral feeding tool, not allowing dietary for this patient, but we know with endoscopic treatment, we really should do the treatment as soon as we do the diagnosis. And as I said that, after three weeks, the rates of clinical success goes down to 7%. And again, this is another study showing very similar rates. Why is that? Because as I said, most of fistulas are late. So in most cases, you have leaks which were not treated, and then they turn up to a fistula, they turn into cutaneous, you can have a gastrogastric fistula and gastropulmonary fistula. So in most cases, when you don't treat well the leaks, you're going to have a fistula. So again, treat this patient early, this is the most important message in this talk. And this is a very interesting slide, when you're going to treat a leak or a fistula, especially leaks, because fistula, you have some kind of drainage, because you have two electrolysis surfaces connecting. But when you have a leak, so you have just a defect in a collection, you cannot use air. If you use air, also due to inflation, you can disrupt the collection, and then you can have a pneumoperitoneum, and that's why you should do underwater procedures. So look at this video, you are inflating the balloon with water, and you see all the water filling the balloon very slowly. See, there is no high pressure. And when you change the water for air, see the pressure goes up to the distal part, and then that's why you have the disruption of the collections, and then you can put the patient in a very bad situation. So now we're going to talk about the endoscopic approach for the treatment of these defects. So we have closure, cover, and draining techniques. The closure techniques include tissue sealants, clips, and suturing. Covering includes stents, the esophageal stent, and also the bariatric stent. The cardiac septal defector pruder, and the draining techniques, which nowadays is my preferred approach. So we have endoscopic internal drainage with double pigtails. We have the septotomy procedure, and we also have the endoscopic vacuum drainage. So in the next slides, we're going to discuss and show some cases including all these techniques. So tissue sealants, and this is quite interesting, but nowadays just a few people are using. So you can use just in very select cases. When you have a small defect with a small tract, a tiny tract, you can use. So when you have a low depth and a diopter smaller than 10, it may be used. In most cases, more than one section is required, and sometimes associated with a high cost. So I use it just in very select cases. It's not my preferred approach. Conventional clips, you should never use this because they are not effective. So you're just going to spend money, and you won't have a good result. So do not use conventional clips for these defects. Cat-mounted clips, this is a quite interesting approach. So you can see in this video, we have a small defect. We bring it inside. We do such and bring inside the cat-mounted clip, and then we deploy the clip. So it can be used just in small defects, 3 to 20 millimeters. You have a quite interesting clinical success, 60%, especially when you do combined therapies. For example, you place a clip, and then you can place a stand, something like that. And again, when you have a collection, you need to have an extended drainage. You never can just block a collection because the patient is going to be worse of the infection. So this is a basic principle that we need to understand before treating this patient. So when you have a collection, you need to drain. You can choose another technique than endoscopic internal drainage. But if you use clips, you need to do the external drainage. It's similar for the stand. So be careful when performing this procedure. Endoscopic suturing, it's the same thing. If you have a collection, you need to do external drainage. But my experience is not good with endoscopic suturing for these cases. So for fistulas, I do not recommend it. You see this 31-year follow-up, and you have just 31% of closure of fistulas. So it's a very low rate. And I know in the US, it's not a real high cost. But in other countries, it's a high-cost device, and with a very low clinical success. So I personally do not recommend it. Stents. Stents, it's a very popular approach. Several physicians use it, even if there was not a lot of experience in bariatric endoscopy. It's very effective in the acute and early weeks. You have a clinical success higher than 7%. But you should know it's associated with adverse events, shift migrations. So in this meta-analysis performed by our group, we showed a migration rate of 30%. So a very high migration rate. So be careful when using stents. And due to the high rates of the conventional stents, these are Fagioli stents. Recently, they launched the bariatric stents. These stents are longer and larger. And it was customized for sleep. But they are not better than the conventional stent. Here you can see a study performed by our group in a multi-center study. We showed a clinical success rate of 78%. Which is very similar to the conventional stent. But the problem was the adverse events, which I will show in the next slide. And very interesting in this study, 37 patients. Of these patients, the ones who failed the stent treatment, we performed other endoscopic therapies, such as ectotomy, endoscopic internal drainage. And our clinical success went up to 94.5%. Just one patient went to surgery. And this patient went to surgery because the surgeon didn't want to try another endoscopic approach. Because I'm sure if he tried, we would close it. So endoscopy nowadays, in my opinion, it's the best approach to treat these defects. Adverse events related to bariatric stents, as I said in our study. So we had 80 migrations and two patients required surgery. As you can see in this picture, so the stent migrated to the jejunum. We found the stent by doing enteroscopy, single-valve enteroscopy. But the problem is the stent is so large that it could be removed. And this patient went to surgery. We had esophageal perforation and a lot of ulcers, contended perforations. So be careful. This stent is not better than the other one. And you have a high rate of adverse events. So it should be used with caution and with physicians with experience in bariatric endoscopy. This is a meta-analysis, which we were part of this group, of this study. And see, comparing both stents, again, there is no statistical difference between these stents. In this study, we showed that the customized stent is even worse than conventional stents. A clinical success of 82% and a migration rate of 32%. And in this meta-analysis, which is an updated analysis from the first one, the clinical success was 90%, which, in my opinion, is very high. And maybe most stents used just in acute and early leaks and not in all kinds of leaks and fistulas. And this is another study showing the stents in the treatment of chronic staple iron leaks. So I tell you, this doesn't work. So stents are not indicated for late and chronic fistulas and leaks. So I really do not recommend. After 30 days, I don't believe it works. So look at the migration rate, 47% migration rate and low efficacy. So I'm sure I do not recommend it for chronic leaks and fistulas. So how do I do it? As you see, this is a leak and not a fistula. And you see the container. You go to the cavity and you see the external vacuum therapy. The patient was doing. We found that after a leak, we placed the stent. And after four months, this patient came back. And when he came back, we removed the stent. And look at that. We can see a very normal anatomy. So it was really amazing. So when the patient has an external drainage and you need to reconnect the leak, stents are a good option. Cardiac septal defect occluder. This is a very interesting device. We have a lot of experience with this. We performed this meta-analysis with 19 case reports because we didn't have more than two patients. And the clinical success was 77%. And the adverse event rates was 22%. And most of them were migration and fistula enlargement. And then we did this multi-center analysis of the efficacy of the cardiac septal occluder in the treatment of post-bariatric leaks and fistulas. And see the results. We're very impressed. So we have a clinical success of 90%. But the most important data of this study is the 97% success rate in late and chronic leaks. So late and chronic leaks and fistulas. So when you have an epithelial tract, when you have a fistula with an epithelial tract, this works very well. So for example, I'm going to show some videos in the next slide. But when you have a gastrointestinal fistula, a gastrobronchial fistula, it's a very interesting device. So we usually perform placement of cardiac septal defect occluder when other endoscopic techniques fail. So this is an off-label use, a very high cost. And we have other therapies. So after trying all the other therapies, when you fail, you can go to the cardiac septal defect occluder. And the success rate when you do the adequate indication is very, very high. How I do it? So here you see a patient with a bypass. He has a bypass leak. We place it at a stand. And after four months, we remove the stand. And the patient had a defect. So you can see the defect, a chronic fistula, a chronic gastrocutaneous fistula. And we decide to place the cardiac septal defect occluder, see the epithelial tract. And we place this device. And this is a very amazing case. Here you can see the fistula tract. So you can see the area in the fistula tract and the device here. So we inject at the same time after placement, like two minutes after placement. And what I see is the complete closure of the defect. So this patient, he became my friend. And after this procedure, this patient went to a wedding. And during the wedding party, he sent me a picture drinking beer and said nothing was going to his belly, to his abdomen. So he was so happy. And he did the follow-up with us. And as you see in this video, we will publish this video. And after one year, we can see the cardiac septal defect occluder in the same place. And the patient had no symptoms. And then after two years, he came back again with no symptoms, just for follow-up. And this is what I found, like nothing. We didn't find the cardiac septal defect occluder. And see how interesting? And I didn't know where was the device. It was migrated to the cavity or migrated to the limb. And we performed an upper GI series and see there was no more cardiac septal defect occluder. So they still migrated and the patient eliminated the stem. So very, very interesting procedure when we came to. We also use the cardiac septal defect occluder to treat gastrogastric fistulas. We know the endoscopic treatment of these defects, the effect is very low. So when you do suturing, the technical success is 100% in most series. But the problem is the long-term follow-up, as I showed before, is just 17% for gastro-gastric fistulas. So in this thing, doing this low rate of success, this low rate of success, we try to use a new approach. So we placed the cardiac septal defect occluder. And this is a very interesting case because after placement, the patient lost six kilos and had no more symptoms related to reflux. So it works very well. In this case, we published this. But we tried again in a large fistula, a large gastro-gastric fistula. And the device migrated to the pouch. And the patient had obstructive symptoms to the pouch. So we need to remove the stem. So we are still studying that to understand which is the best indication. And now we're going to talk about the draining technique. So first, we're going to start with the double big tails. And double big tails technique is very interesting. So we can do endoscopic internal drainage, similar to pseudocyst. So we found the orifice. We used fluoroscopy. We placed the stem. And we replaced the other big tail. We placed it in the gastric lumen. So this was a leaflet. So you see one big tail in the cavity and the other big tail in the lumen. And then you can have the drainage because you reduce the pressure of the collection. So it's a very interesting technique. And the results are impressive. So when you use it in bypass, you have a 97% clinical success and a few rates of adverse events. And when you use it in sleeve leaks, this is a systematic review. You can see very high clinical success, including experts and non-experts. So it's a kind of easy procedure. You just place a guide wire and then a stem. So any therapeutic endoscopy can do it. And the adverse event rate was 13%, not so low as we thought, with some migration, bleeding, and perforations. And then we have recently, Donatelli published this series. It's the largest series published yet. And 617 patients. And the clinical success was quite high, 84%. And failure in 15% of patients who went to surgery. But it had 4% adverse events, such as embolization, surgery, neoperitoneum, and migration. These adverse events, I think, are related to the use of biliary stands. Because biliary tails, they are quite hard. They are not soft. And that's why maybe they touch, for example, the artery. And you can have bleeding. And you can have perforations from other organs. So we are doing this technique. But we are using the stands used by the urologic surgeons, not by the endoscopists. For stones in the kitchen. So when they use these stands, they are more soft. And this kind of stands we are using. It works very well. We will have these stands in 24 and 26 centimeters by six or seven friends. And these stands, you can cut them in the middle. And then you can have two stands. And you place the big tail in the collection. And you place the other part down in the sleeve or in the bypass. You can place it close to the anus in the sleeve and in the front limb in bypass. So it's a quite interesting approach. Our results are similar to the use of the biliary stands, but with no adverse events. So I suggest you to try this. This is another study, including the use of big tails for primary and rescue therapy. And again, for primary therapy, it's better than the rescue therapy. But the results in the rescue therapy were pretty good, 82%. And that's why I think drainage techniques are better than the others. And this is a case performed by myself, a patient 35 years old. Six days after the vasectomy, we did the endoscopy. We found some fluid and a residual fungus. And you can see the orifice of the lip. So in this case, we use the compress. And you can see a very large collection. And in this case, what is the best approach? So you cannot closure because this patient didn't have external drainage. So we could not use tissue sealants, cat mountain clips, suturing, and stents. We could not use the cardiac septal defect computer because this is an acute leak. Septotomy could not be performed because there was no septum. And the endoscopic vagal therapy was an option. But the problem is the position of the leak was very on the top. So we need to do a retroflexion of the scope. So placement of the nasogastric would be very challenging, as you see in this video. So we decided to use double pigtails. We placed two double pigtails stents, as you can see. This patient went home three days after the procedure with antibiotics. And after one month, she came back and see how interesting. So after just one month, there is no more collection. So we treated this patient. And she had a stenosis. As we talked before, when you have stenosis, as you can see, how hard it was to transverse the sleeve with the endoscopy. When you have a downstream stenosis, you need to dilate it. So we dilated with a chalazobalone dilation up to 30 millimeters. And you can see the waste disruption. And then see how easy it was to transverse the sleeve with the gastroscope. So this shows the efficacy of a chalazobalone dilation as well. And we are talking about downstream stenosis. So I'm going to talk a little bit about that. It's not our focus on this talk, but I think we need to discuss a little bit. So sleeve stenosis, it's the most common find nowadays because everyone is performing sleeve, at least in Brazil. There is a lot of sleeve surgery. So you have two types of stenosis. The mechanical stenosis, which usually occurs in the body. In the axial deviation, which occurs at the level of the scissor angularis. And these ones are a little bit harder to treat. It's due to the indentation, progressive rotation of the staple line from anterior to posterior. And this is challenging to treat. So this is the way we treat sleeve stenosis. So before two to three weeks, we did not do anything for these patients. Because most of these patients can solve the obstructive symptoms with the conservative treatment. Sometimes you have the edema of the surgery. But if the patients still have symptoms, you need to perform an upper GI series and an EGD for diagnosis. And then you can treat by endoscopy at the same time after diagnosis. So we usually start using pneumatic balloon dilation. We always try three dilations. We start with 30 millimeter balloon. Then we go to 35. And depends on the decision is video case by case. But it can go up to 40 millimeters. But usually we don't go more than 35 because of the risk of perforation. So this is some results. So we have 80% clinical success. And this is the same video that I showed. And we treated this patient with a very small stenosis. We already showed this video. So I will skip that. And if we fail pneumatic balloon dilation, in most centers, people perform a stent placement. We do not use stents anymore. And I will show why. But if these patients fail to stent, they usually go to surgery. And surgery has a very high rate of success. As you see, this is like 90%, 80%. And most of the patients go to revisional surgery and change from sleep to one-way gas bypass. And the stents have a high clinical success rate in literature. But it's also associated with higher rates of migration. And finally, this is why I do not use stents. So if the patients fail pneumatic balloon dilation, I am performing endoscopic tonic-strict urotomy. And we're going to show this procedure. This procedure was described by Chris Thomson. And I published this with him. So you have the stenosis. You can do similar to a point. You can become five centimeters proximal to the stenosis. You do some causal injection. Then you perform the incision. And you do the subcausal tunneling. So after doing the subcausal tunneling, you're going to find the area of the stenosis. You're going to find a very fibrotic area. And then you can cut these fibers. And also, you can cut the muscular layer to improve this stenosis. So this is the procedure performed by Chris Thomson. And after you perform the partial myotomy, you can close this using suturing device or hemoclips. It doesn't matter. It's just important to close. And this is the pre-and post-procedure. And now you can see the upper GI series are really improving in this patient. And so I'll read his symptoms. And this is the technique. When I came back to Brazil, we described this technique, which we do the full fitness myotomy. And so we do the same technique as Chris. And then we do the full fitness myotomy. As you can see here, it's very interesting. You can see the staple line. And it goes down to the staple line. So we are really doing a full fitness. And then we cut this, and most of the patients have a very good response, so it's a very interesting approach. We are performing, we're going to publish a series soon. And after bypass, this is very common as well, so you can dilate these patients with hydrostatic myeloma dilation. Usually three sessions are enough to achieve a clinical success of 95% as shown now in the series. And the risk of adverse events is usually related to ischemic segments. So these patients are more hard to treat, and then you need to do more dilations, and then doing more dilations, you can have like bleeding and perforation. So be careful in these refractory cases. So this is some cause of the refractory gastrointestinal ostomosis stenosis, and it's usually associated with ischemic segment to a large part because you have excessive acid production, and then you have chronic ulceration in late future. So these chronic and late are very hard to treat by endoscopy. And the treatment options are steroid injection, incisional therapy, and the use of stents. So recently, most centers are using the luminal posomatter stents because you have a low rate of migration, as you see in this paper, and this is a case. We published it, so you see we applied the first flange in the jejunal lymph, and then the second flange in the palm tree. And the results are quite interesting. You see here a 70% clinical success for refractory gastrointestinal stenosis, and it's a quite good result. Septotomy. So this is another endoscopic internal drainage technique, and here in this study performed by Giorgio Barretta, our friend from Brazil, you see 27 patients with a clinical success rate of 100%. So when you have a septum like this picture, you need to cut it. You need to communicate this cavity with the lumina. So when you do that, it's similar to a zinc. So when you have a zinc in the vertical, you need to cut the septum. So here it's exactly the same mechanism. And this is a case, this is a video from Giorgio Barretta, a very interesting case, a patient 38 years old, and after a bypass, and here you're going to see the leak. You have a very large collection, you can see necrotic tissue, some purulent fluid, and here the septum. So you need to cut, otherwise you're not going to treat this patient. So the best approach for this case, when you have a septum, for sure, is the septotomy. So always cut the septum, this is very important to achieve success. Other approach here would be endoscopic laparoterapy, and endoscopic internal drainage would be a great option as well. So he performed the septotomy with the armoplasma coagulation, very aggressive procedure in an experienced hand, and you can see he cut all the septum, and then he has to communicate between the septum and the cavity. The most important tip in this case is to cut until the staple line. Don't go further than the staple line, because you're going to have a perforation. This patient went home one day after the procedure, and when he came back, you see this very small cavity, no fluid, no fluid, and the patient was doing fine, he didn't do anything, and after three months, the patient came back with the complete closure of the defect. So when you have the septum, the message here is when you have the septum, cut it. This is another study, clinical success of 100%, again explaining why you should treat this patient. He included just late fistulas, so septotomy for late and chronic fistulas are essential. This is another study, the clinical success was 80% in sleep leaks, but interesting because the authors first dilated and then performed the septotomy. Here, we do different. First, we do the septotomy, and then we do the dilation, so I don't know if it's related to the lower clinical success of this study, but something we need to study. He proposed this algorithm, and I completely agree. I think for late and chronic fistulas, endoscopic draining techniques are very good, and especially when you have a septum, you need to do septotomy. So how do I do it? I can do it using both APC and any kind of knife you can use. In this case, we were using IT knife because the fellow was going, so we took a little bit of care to not have a perforation, and it's a very interesting procedure. You see in both approaches, we cut all the septum, and we have a complete defect closure, and this patient is now treated. Now, we're going to discuss endoscopic buccal therapy. The mechanism of action is the micro-deformation and changing perfusion, which improves angiogenesis. You have the exudate control and also the bacterial clearance. You have three types of devices nowadays. The open-bore polyurethane sponge, which is the most traditional one, the open-bore fume, which was described recently by LOSC, and the low-cost modified APC, which was described by a Brazilian friend, and we are using this technique a lot. We're going to talk about that. So when you have a defect, a leak or a fistula, you can place the endoscopic buccal therapy in an intraluminal position or an intracavitary position, and when you have a cavity, you always use intracavitary. When you don't have a cavity, you can use intraluminal. The adverse events related to the procedure usually are the discomfort of the patient, but to be honest, in my personal experience, I don't have that. So when we explain to the patient and show the benefits, they usually accept very well. And sponge migration and repeat procedures were the most critical complaint of physicians. But now, with these two new techniques, I'm going to show this is very different nowadays. So this was the traditional one. The problems of the traditional device, the challenging placement and removal, and usually we need multiple exchanges and prolonged procedures because it's very hard to place, so it takes a lot of time, and you need to change a lot because if you wait more than five to seven days, the tissue growth is going to go in the sponge, and it's going to be hard to remove. This is our case. We used this sponge, the conventional sponge. So we had a patient, the patient who had the esophageal perforation. We tried to treat it, the esophageal perforation, after a biopsy placement, and this patient went to surgery, and then he had a fistula thrown the medicine into the esophagus. It was a very, very large fistula. This patient was in a very bad condition, and we closed it using the endoscopic faculty therapy, nine sections. So it was a pretty interesting procedure and a beautiful result. And with these new devices, the low cost and the open port, you have an easy placement. You go direct to the nurse. You don't need to remove the esophagus through the mouth, and then you use the sponge. You have a reduction in the procedure time, a longer interval between EDTCs and exchange, and a lower rate of adverse events such as bleeding. So the difference of these two spots are the cost. So this one, you don't spend more than $30, and this one is quite expensive. So in Brazil, we are using this modified PT. So I'm going to teach you how we do it. So we use a nasogastric tube or a triluminal, and then we need to use a gauze and antimicrobial incised drain. And then you use other materials such as a needle to do multiple rolls in the drain. We use some suturing, and we use the wall aspiration, which I'm going to show you. So first, we cut the gauze. We use just a half of gauze. You don't need more. You don't need to be large. Then we take the fenestrated portion of the nasogastric tube, wrap the fenestrated portion, and then we use the antimicrobial incised drain to wrap the gauze around the nasogastric tube. After that, we do multiple rolls. After that, we do fixation of the system. We use a nylon suture. And with this suture in the middle, it's going to help a lot during endoscopy to show the best position. And then in the end, we do multiple rolls. Sorry. So we use the sutures to fix that. So we use one in the proximal part, one in the distal portion, and finally one in the middle, which is going to be a guide to the endoscopy. And then we make several rolls with the needle to create the system. We use the aspiration of the wall to test the device. Yeah, a very, very good aspiration. And just to show you, we can use in a triple lumen, just, you know, feeding and gauze to this compression tube. And with this, this system allows drainage and nutrition with just one tube to the nerves, reducing discomfort. So this system can just be used as an intra-luminal approach, not an intra-capillary approach. And this is the way we do the, we use the suction from the wall. Despite the vacuum type machine, this is going to be much, much cheaper for the hospital. So we use the intravenous catheter to any gauze. We make a hole in the aspiration tube, which is connected to the wall. And with this, we're going to maintain a negative pressure between 75 and 150. So this negative pressure, it's controlled by this intravenous catheter. So you don't need the machine because you have this to control. And you also keep the vacuum of the wall in the maximum force. So it's very interesting and cheap, this approach. That's why people in Brazil are using this a lot. And the results of the vacuum therapy, it doesn't matter which technique you are using. It's very high, so clinical success, 100%. And this is a case that we performed. So a 30-year-old woman, laparoscopic sleeve gastrectomy. We face lift. So as we said before, we use the underwater technique. And we follow the staple line. We follow the staple line. We found the defect. And we found this leak. So we do a counter-study. You see here the leak. You see kind of a stenosis here. So what's the best approach for these cases? So for this case, the vacuum, I'm sure, was the best approach. You could use stents as well. But the other ones, it was not indicated you could not perform the other techniques. So you need to choose between stents or endoscopic vacuum therapy. And we choose for stents. We have a very high efficacy. And the stents is associated with migration and also a need for external drainage. So that's why we use endoscopic vacuum therapy in these cases. And we use the triple lumen jejunum feeding and gastric compression tool, as you see here. So you have, you can, it allows drainage and nutrition. We place the EBT system in the leak. And here you see the aspiration very well. So this patient was in the hospital just for 15 days. We did not perform exchange because the system doesn't need to do that as the sponge one. So you do just the select cases. And at the end, you see the results. So we treated the patient in 15 days, allowing nutrition during the 15 days. So that's why I believe it's better than stents and no adverse events. And also we had an improvement of the stenosis. And this patient had no more symptoms. And this is a result. We're using the similar device, but with a higher cost. The open portfolio and clinical success was 87%, including most cases, most patients with latent chronic leaks and fistulas. So it's a very interesting approach. And this is an analysis performed by our group where we compared the EBT with the stents. And in terms of successful closure and lower treatment time and lower mortality rate, the stents were better. The EBT was better to the stents. So EBT is superior to the stents when we talk about defects in the upper jet rafts with similar rates of adverse events. So this study is also showing the benefits of EBT. And you can also perform a combined approach. These patients are very complex. So in this case, the patient was almost dying. She was very bad. We placed the modified EBT inside the cavity. This is a case performed by Newton, our colleague. And after the patient was better, they performed laparoscopy and found the limb, the jejunal limb. And then we placed a guide wire and a stent. And after four weeks, we removed the stent. And what we saw was a complete healing. And you can see a very normal anatomy after when I asked my patient. So combined approach is also effective. And to finish my presentation, I want to do a very quick summary of this presentation. So the talk will be available for ASGE members. But this is a very nice resume of this talk. So this is our indications, the disadvantage of each treatment, and my experience using this device. So for tissue sealants, I think they are associated with a low efficacy. They require multiple sections. In Brazil, there is a high cost to use this device. And I don't believe it's effective for acute and early defects. I just think it works for late and chronic with low depth, with a very thin tract, then you can use. And usually, you need to combine approach. So sometimes you can use a stent and place the glue, or place the glue and then a cap mounting clip. But it's very, I just use in very select cases. The cap mounting clips, in Brazil, we don't have a lot of experience because they just came to Brazil now. But what I think regarding the literature, it can work. And not if it's smaller than two centimeters. If you have a collection, you need to do external drainage. But in my opinion, I think they just work for small defects in late and chronic fistulas without collection. So in select cases, it may be helpful. Suturing, I do not recommend it. As I said before, there is a very poor long-term clinical success. And in Brazil, it's a high-cost device. And again, a conventional clip should not be used to treat any kind of leaks or fistulas, not just after bariatric surgery, but after any kind of surgery. Covering techniques, they are effective. And you can use with quite a good clinical success. Stents, as I said, you can achieve a very high success rate when you indicate just an acute and early leak, not for chronic leaks. You also need to do external drainage. So this is an issue. And be careful because the stents can migrate, can do serrations and also perforations. So when you use a stent, be careful. The fully covered stent is associated with higher rates of migration compared to the partial covered stent. But when you use the partial covered stent, usually you cannot keep for more than three weeks. If you do that, it's going to be very, very hard to remove. So if you don't have experience, I do not recommend it. And bariatric stents, as I said, our experience was not good to use this stent. So I do not recommend that. It's used just in select cases. So when you have a patient, he already has external drainage, so the patient is well, and he doesn't want to stay in the hospital to do the endoscopic vacuum therapy. And he has a sleeve with a small stenosis. So in this case, maybe the bariatric stent is a good indication. Finally, the cardiac septal defect occluder. As I said, it's off-label use, a very, very expensive device, so you just should use it in late and chronic defects after failure of other techniques. But it's a really good device. I do approve it. And to finish the presentation, the drainage techniques, as I said, nowadays are my preferred approach. So septotomy, when you have a septum, just do it. Don't think about other techniques. Do the septotomy, and for sure your patient will be better. Endoscopic vacuum therapy. If you have experience with this device, if you know how to talk to patients, I do recommend it. So it's a very good device, very high rates of clinical success. With this modified EBT, we have easy placement, reducing procedure time, and no need for repeat procedures. So in some cases, we just change the system after 15 days. It all depends. When you have a cavity, we need to change every week to reduce the size of the system. But usually, when you're doing prolonger, you can keep it for 15 days. And double pigtail stents, it's a very interesting approach as well, very high clinical success rate. And this patient is good because you can place the stent and send this patient home accepting oral diet. So it's good. Your patients like this approach because they don't need to stay in the hospital. So it's also another option. And this is also a good slide for those who want to start to do bariatric endoscopy. It's an algorithm performed by our group. We use this, and this is what we do. So there is no precise algorithm, but when you use this, we recommend several approaches, so you need to choose the best one. But based on the time of the leak or the fistula, we recommend some of these approaches. So this is a good slide. If you want a copy, make yourself free for that. And, of course, always treat the downspout stenosis, as we showed during the presentation. So for latent chronic fistula, which was the main focus of this talk, I recommended just the draining techniques. In very selective cases, you can use square-mounted clips, maybe associated with tissue sealant. And the cardiac septal defect tool, always remember, it's a good option when you fail all the other approaches. So in conclusion, endoscopic therapies are safe and effective in the management of post-bariatric surgery leaks and fistulas. Always remember, this patient is a complex patient, and individualized approach is recommended. So don't think, oh, I'm just going to do endoscopic therapy. I just do stents. No, there is no room. So you need to see the patient, see the anatomy, and see how the patient will accept the stent, the symptoms of the stent, or the symptoms related to the AVT. So with the patient, decide for the best option, and make the patient conscious that sometimes more than one intervention is required. And as I said, there is no data to support a precise algorithm for post-bariatric leaks and fistulas, and it's also very important to consider your experience when choosing the best approach. And for sure, if you don't have experience and you should send this patient to a center of excellence, don't try to do things that you don't know how to do it. This is a very complex patient, and if you create more complications, you can increase the mortality rate. And of course, multidisciplinary approach is essential. So these patients, sometimes they come in a very bad situation, so you need a good nutritionist. Sometimes these patients need to go back to surgery. You need extended drainage with the radiology. You need to keep these patients in the intensive care unit. So multidisciplinary approach is really essential. And finally, I want to take the opportunity to invite you to participate on the Bariatric Endoscopy Life Global. This is a course that is supported by ASGE. We created this course with some well-known physicians. The ones who are the directors are Eduardo Moura from my hospital and Chris Thomson, which was my mentor in Harvard. And we have also other co-directors. And this course, it's an amazing course. We perform bariatric endoscopy cases live in 12 centers of excellence around the world. And last year, we had almost 2,500 registrations. And interestingly, we had 98 countries watching our course. So we really invite you to participate. This is a free course. I'm sure you're going to learn about with several well-known physicians performing these cases. So thank you again, ASGE, for the kind invitation. It's always a pleasure to work with the American Society of Gastrointestinal Medicine. Thank you. Obrigado, Dr. Moura, for that very insightful and informative presentation. And again, we want to thank all of you for joining us this evening for this ABE webinar on Endoscopic Management of Chronic Sleeve and Gastric Bypass Fistula. At this time, Dr. Moura will address questions received from the audience. As a reminder, you can submit questions by clicking the Q&A feature at the bottom of your screen. Once you click on that feature, you can type in your question and hit Return to submit the question. So, Dr. Moura, the first question I have for you this evening is, what is the benefit of modified endoscopic vacuum therapy compared to the conventional sponge? So as I discussed in the presentation, so both works very well. The successful closure rates are very similar. But when we do the sponge, the conventional sponge, endoscopic vacuum therapy, it's very hard because you need, for example, you need to use the nasogastric tube to do an X. Then you remove it to the mouth. Then you make the sponge system there. Then you place the sponge. So it's very hard to place the sponge. And the tissue growth around the sponge makes the removal also challenging. So you need to remove, to exchange this device between three to five days. And it makes it very hard for the patient and even for the endoscopy team. And with the modified EVT, it's a very low-cost procedure. So with $30, you can customize your device. And it's very easy to place. So you have a reduction in time, reduction in adverse events, reduction in needs for exchange. So that's why we are using this approach. And a lot of people now are using. We are trying to teach several people. We created a video, a tutorial video on how to do it. And we also can send it to someone. I mean, just send an email, and we can send to everyone. And I'm sure this new approach will help more physicians around the world. Okay, thank you very much for that. The next question I have here, what is the best indication for the cardiac septal defect occluder? So the septal defect occluder, there is some issues in using this device. I know in the US, it's not easy to use of label devices. So as the name said, this was created to be used in cardiac defects. So they use an endoscopy in gastrointestinal tract. It's an off-label use. But it's helpful. So when you have a chronic fistula, so when you have a neptalized tract, you can use this stem because the stem is very strong. So the stem keeps it in place in the cardiac defects. So these things are very, very strong. So when you have a neptalized tract, they stay there very well placed. And with this displacement, during the occlusion, you have the closure of the tract and the closure of the fistula. So when you indicate just in these cases, in chronic defects, with a neptalized surface, our success rate is 97%. So when the indication is correct, when you fail all the other endoscopy techniques, I think it's worth to use this off-label device. Okay, thank you very much. The next question I have for you. How many times do you try pneumatic dilation? So pneumatic dilation with the alkalizing balloon, before we described the structurotomy technique, the subcausal tunneling technique, we used it a lot. We tried several times. But nowadays, we try the maximum of three times. So we dilated the spaces to 30 millimeters, then we go to 35 millimeters. And if it fails, we usually go to structurotomy, because it's a very safe procedure, because you know what you are doing. So we are doing the tunneling, you see all the tract, and then you just spread the muscular layer. You can do a full thickness myotomy. And then you just close with the incision, similar to a point procedure or a G-point. So it's safe. And sometimes the balloon is not safe, because when you are dilating, and you are looking at the fluoroscopy, you see the waste, and there is just the rupture of the waste. So sometimes you can have perforation. So I think for people who have experience with subcausal tunneling procedures, this new approach may be very helpful after the first failure of alkalizing balloon dilation. All right. Thank you very much. And it looks like we have time for one more question. What is your approach to gastrogastric fistulas? So this is a very good question. In my opinion, my personal opinion, endoscopy is not so good for treating these patients. So when you use APC and suturing, APC and over-the-scope clips, while you see it, the technical success is very high. So during the procedure, you do the procedure. When you finish, it's beautiful. But after one year, the rates of success, it's lower than 20%. So I don't think it works well. That's why we try to change the cardiac septal effect to occlude it. But as I said, we don't have data to recommend this procedure. But what I think sometimes when you have a gastrogastric fistula smaller than 10 millimeters, the orifice is smaller than 10 millimeters, you can try endoscopy. But when it's larger than 10 millimeters, I don't think endoscopy is a good option. And I think surgery is the best option. We know some people are doing the endoscopic gastropathy in the remnant stomach. I know Chris Thompson has a lot of experience performing this procedure. And you have quite an improvement in the weight loss, but you don't really close the fistula. So some patients have reflux. And that's why I don't think this is also a great approach. For defects larger than 10 millimeters, and the patients with symptoms, of course, with weight regain, with reflux, for these patients I think a surgical approach would be better. All right. Well, thank you again, Dr. DeMotta, for being here today with us. And before we close this webinar, I do want to launch a quick poll to check the quality of this presentation. Your experience with these learning events is important to ABE and ASGE, and we want to make sure we are offering interactive sessions that fit your educational needs. Please go to the networking lounge and fill out a quick survey that will take you less than one minute to complete. We would greatly appreciate your feedback. We will leave the poll open for the last remaining minutes. And while you're filling out the survey, I want to thank you for joining us for this presentation on Endoscopic Management of Chronic Sleeve and Gastric Bypass Fistula. A recording of this webinar will be available in approximately one week on ASGE's GI Leap, and you will have ongoing access to the recording as part of your registration. If you have questions about GI Leap, please contact our education department at education at asge.org. This concludes our webinar, and thank you all again for joining.

webinar

Association for Bariatric Endoscopy

endoscopic management

chronic sleeve

gastric bypass fistula

leaks

fistulas

bariatric surgery

treatment options