All right, good morning everybody. Raj, Adam, thank you for the invitation. So, I'm going to talk about endoscopic flow thickness resection, and it's kind of a challenge because all the speakers here are so passionate about everything they do, and so hopefully I'll try to bring that passion. No disclosures. All right, so the objectives are to kind of review the technique, review the data, and show so when they sent this to me they said present cases, it was plural. So, they didn't say present patients so I have one patient who I did two on, so I'll show you the technique. All right, so what is a flow thickness resection device? Anybody not seen it at all? Everybody seen this device? Some of you, okay. So, what it does, it allows for flow thickness resection. Flow thickness meaning going all the way through the muscle layer, even down to the serosa. And so, if done correctly, the transection happens only after you've closed the defect. So, basically you're grabbing I'll show you images here in a minute, but you're grabbing the whole thing, you're closing underneath it, securing the tissue, and then you're transecting above your clip. So, the closure's already there and then you're cutting above the closure. So, this is the device contents. You've got basically an over-the-scope clip. Okay, here it is. So, you've got this over-the-scope clip instead of you mounting it, it's already mounted for you, and it's preloaded on this I mean, I'm sorry, there's the clip and there's the thread, of course, and there's this long sleeve that actually goes over the colon, the colonoscope, I'm sorry, and if you can see here, there's this kind of a thread, a wire that through it goes the snare. So, the snare is already preloaded for you. You don't put a snare through the channel of the scope. Actually, you put the scope through this sleeve here, it comes all the way to the end, and then this sleeve goes over and there's tape so that the chances of it moving or changing lengths during your procedure is minimized. Of course, you've got here the hand wheel and the thread retriever, which is standard, just like over-the-scope clip. With the device comes a marker, a marking probe, and this grasper. The size depends on if it's a colonic, if it's an upper scope, or if it's a diagnostic over-the-scope device. So, the technique, and this is just from their website, nothing I'm making up, basically, you mount the cap on the scope and the snare's, as I said, running through that protected piece of plastic outside the scope, and that sleeve is, again, preventing any entrapment of tissue between the scope and the snare. And then, if any of you have not deployed an over-the-scope clip, you basically bring the tissue in, and then you turn the handle, and it deploys the clip. One thing, for those of you that have done this quite a bit, not necessarily this technique, but the over-the-scope clip, when you deploy it, there's a tendency for the tissue to go away or the scope to come back. And I've had one instance where I was closing something in the OR for an acute perf and what have you, and as much as I thought I had grabbed the forceps, or actually it was an alligator rat tooth, and pulled the tissue inside, as I was doing that maneuver, somehow it slipped through my hand, and the over-the-scope clip actually grabbed my rat tooth. The surgeons enjoyed it, because they're like, oh, you're using a bear claw and a rat tooth, what do you have, a zoo or something? So they made fun of me that day. So I've learned to, when I pull these things in, what I use, and everybody uses something different, but I make sure and I, you know, I'm not going to do the finger, but if this is the snare, or the alligator rat tooth or whatever, I anchor it like this. So if I just do this, I'm afraid it may slip. So I actually do it like this, and anchor it so it doesn't move, and make sure that's inside. And as you turn, for this device it's even more, have somebody hold the scope for you, to avoid that movement as you deploy it. After you've deployed it, and you know it's released, then your assistant will cut, as you press on the pedal, and you're cutting basically above the tissue. And again, we'll show some pictures and demonstrations here. So there's three devices, and they all have different sizes. This one is called the diagnostic full thickness resection. So this is the scope, it's mounted on the scope, and so if you look at the widest parts, it's 19.5 millimeters, it's fairly large. The opening here of the cap is 12.1 millimeters, and the depth is 23 millimeters. And so those numbers basically tell you how much you can take, how much can you pull in. You know, you're not going to be pulling in 5 centimeters all the way in. I mean, it's only 23 millimeters deep. And it goes over the channels, a scope with a diameter of 10.5 to 12. So why would you use a diagnostic full thickness? Well, how would you use it? So you go to a normal area, and you're probably thinking, why would I ever use this? I'll show you in the next slide. You grab the tissue that you intend to take out, you pull it in, okay? Once you've pulled it in all the way up to the top, that's when you release this device, and the snare goes above where this closure is, and it cuts it. So now you have what looks like normal tissue, but the purpose of this diagnostic full thickness resection device is to get deep, so to see the muscle layers for basically Hirschsprung's disease, ganglion neuritis, or some other amyloidosis, etc. So that would be the reason. The only study I came across was a study of four patients for this. But it's a proof of concept that you could use this in these situations where you need to see what's happening in that deep layer. This is the one that's most commonly used, which is the colonic full thickness resection device. So it's big. I mean, you've got here a diameter of 21 millimeters, so if you're going to go through significant diverticulosis, think again, okay? So your scope is what, 12, 13, or even smaller? So this is very large. The cap, the inside is 13 millimeters. The depth is 23 millimeters. So that right there makes you think about what can you do with this device. It goes over a scope diameter of 11.5 to 13, and a working channel minimum of 3.2 to allow for the threat to go through. And then this is the third device. This is the gastroduodenal full thickness resection. Again, the entire width of the device comes to about 19.5. And if any of you have tried passing an adult colonoscope through the oropharynx, you know it's a challenge, okay? So imagine passing this through. It's a challenge. And so the inner diameter is 12.1, and depth is about the same. This goes over a 1T scope, therapeutic scope, because you need a large channel. So to overcome the challenge of passing this through the oropharynx, they have this, with this device comes a wire and a balloon. And so you thread the wire across, and you come to here to the area of narrowing. You pass a balloon, and you inflate the balloon. It's a 20-millimeter balloon. And so once it's inflated, it kind of opens up the track for you, and then you kind of follow it across. Then once, of course, you're across, then you deflate the balloon and can advance your scope. So the technique for the colonic full thickness resection, or even for the upper, but basically use this marking probe that they have, and you mark around. And the reason this is important, not like the EMRs where you visualize and you can just keep going, you know, next, next, next, because you want to ensure before you deploy that you have it all in. And the purpose of the marking is if you can see your markings inside that clear cap, then you know you've captured the lesion. Then you can deploy safely. So your scope, you have your grasper, you grab it, as in here. Again, you pull it inside. Now the difference than EMR is the purpose is actually to grab the deep layer, the muscularis propria, and bring it all inside. And so you can see here you're bringing your forceps, or the grasper, all the way up to the scope, even inside, I mean all the way in, so that you get as much tissue as you can inside that clear cap. So that when you deploy your device, you're deploying in a normal area with a clear margin with the muscularis propria inside, as depicted here. So when would you use this? Some of the reasons that you could use this, compared to the other techniques that you heard earlier, again, are non-lifting. This seems to be a recurrent theme. The more and more we do EMRs, the more and more there's these recurrence, or harder to take areas, or scarring areas. Early cancers, and I'll show data in a little bit, for treatment naïve or re-resections, adenomas at difficult locations, appendiculorifice or the diverticulum, or subepithelial tumors. Of course, the goal of this is to get an RO resection, completely out, no problem, you're done with it. So how can you select, as we heard in our talks earlier, how can you select the best lesion to apply this technique to? And that's the purpose. If you can find the right lesion for this, and you can do it, then that's a success. So it depends. It depends on how big the lesion is. If the colon wall is fixed, or if it's loose, because remember, you're dragging the entire wall inside. So if it's fixed, it's not going to work. It needs to be loose. If there's scarring, if there's rigidity, those are things that are not going to help you. And the volume of the lesion. We usually look at a lesion, and we just say, oh, this is like a 5 by 6 or 20 by 25. But it's the whole volume as you're dragging it. So if it's long, you're not going to be able to drag. If it's nice and round, then if you pick the center and pull it in, it's all going to come in. And in general, given the diameters and the measurements that I showed you earlier, if it's more than 20 millimeters, I should put millimeters in there, with scarring or malignancy, probably that is not a good candidate for this procedure. Because again, the chances of it coming in entirely are probably going to be very low. Okay. We showed different techniques to taking out polyps from the appendix, from ESD to underwater, to colostomy, to everything. So this technique also can do that. So every technique can take on the appendix. I just wonder how many polyps are there that go in the appendix. Well, there seems to be a lot, right? And we've all seen them. So this one also, this picture, here you have the appendix. And despite what Dr. Uthman said, where he can actually go in all the way through and invert everything, this tries to do that. But again, it all depends. So if the polyp is still here and you're able to get it all in, but you'll never know until, of course, the specimen is actually out. I mean, you won't know that. But if it doesn't look too deep or you can actually see the interior margin or the deep margin and you pull it in and deploy it, then you have it. So is there data to support this? And how safe is it? Well, this is a study, a multi-center study of 66 patients. Okay. And 61 are extended into the appendiceal lumen, where it was felt like it was going in deep. About 15 millimeters was the mean size. Technical success, about 90%. Clinical success, 80%. RO resection at 93%. However, it is a higher risk procedure because you're actually closing the appendiceal orifice. So the appendicitis risk was 17%, basically in 10 patients. And 6 out of those 10 patients, so 60%, required surgical appendectomy. And, I'm sorry, recurrence rate was about 12% because, again, it wasn't all RO resections. So if a patient has had an appendectomy, you know, it's great. But if they haven't, just keep that risk in mind if you do ever do this. When I've done it, we've covered them on antibiotics and a lot of prayers. So hybrid endoscopic full thickness resection. So several lectures have talked about this, where you have a large polyp and you take the margins out and then you're left with this in the middle. And you can do the hot avulsion, you can do the underwater, you can do whatever. And as Megan Trainor, the singer, said, you know, it's all about the bases. No trouble. So with this technique, basically, you can grab that base, pull it in, and take it out. So is there data to support this? So this was a study, looked at 38 standalone full thickness resection versus 31 hybrid EMR with the full thickness resection. Again, the most common indication was either a non-lifting polyp or a suspected high-grade dysplasia or cancer. And so with this technique, with this hybrid technique, so you've got a larger polyp, you cut, cut, cut, you're left with a piece, you can't take it out, use this. They were able to take out significantly larger lesions, overall, of course. 40 millimeter was the mean, but up to 70, compared with the standalone full thickness resection, which was about 17 millimeters. And again, clinical success, 90%, 91. Technical success, 80. And you'll see this number again and again and again. 90 seems to be the technical success or the clinical success or technical, but the RO resection tends to be in the 80% for these lesions. So what if it's a cancer or you suspect it's a cancer? So this study just came out this month. 136 patients with suspected T1 colorectal cancers. Median size was 15 millimeters. 83% were confirmed cancer. Again, technical success, almost 90%. RO resection, about 80%. The RO resection was 90% for polyps less than 15 millimeters. Dropped to about 70% for 16 to 20, and was only 11% for those more than 20. And so, for this device, especially if you're going to use it for cancer, keep those numbers in mind. 15, 20 maybe seems to be the about the most that you'll be able to get. Anything larger than 20, you should probably not attempt it. 15 seems to be a very reasonable number. So this is one of the last few slides I have. In the Scott Fulton Instruction for Colorectal Lesions, this was a systemic review and meta-assist... Thank you. Yeah, I'm getting something from you. And this is a meta-analysis. So 14 studies, almost 2,000 patients. The majority, almost three quarters were in the colon. Mean procedure time, 45 minutes, not too bad. Technical success, 87%. Hour over section, almost 80%. So that number seems to be recurring and seems to be about right. Procedure associated adverse events, 12%. So that includes basically everything, okay? Recurrence rate, 12%. And that seems to be a high number, but again, if your RO resection is only 80%, you're gonna expect residual tumors. Now, when they looked at, they did a regression analysis, there was a significantly lower RO resection. And of course, higher overall procedure related adverse events for lesions more than 20, okay? And so, again, for this device, you need to probably stay under 20, maybe 15. 15 to 20 would be the area where you might wanna, you know, it varies on other things. Smaller than 15, probably the success of this device would be much higher. Okay, what about upper lesions? So the upper device came a few years after. This study looked at 55 patients for various lesions in the upper GI tract. So mesenchymal neoplasms, adenomas, or hematomas. The majority were gastric and duodenal. And by the way, it's approved for gastric and duodenal, not esophageal. And again, the size of these lesions on average was about 14 millimeters. Technical success, similar thing for the upper, 90%, 93%. The resection was complete in about 77% of patients. Partial resection, 16. Our resection, 68%. And adverse events, 21%. Most of them, again, mild or moderate. So this seems to be a good device maybe for subepithelial lesions. We have a fair amount of them in the stomach or in the duodenum. So this study looked at 29 subepithelial gastric lesions, median size of 11 millimeters. So they're not that big. They're not the big, hunky gists that are two, three centimeters, okay? Technical success, again, around the 90%. Our resection, 76%. Median procedure time, just over half an hour. And then, of course, allowed for definitive diagnosis for gists and neuroendocrine tumors. So if you're able to get it all out, of course, you can assess everything in it. So how does this work? This is one of the other tools that comes with the upper, or you can, I think it's separate. It has this anchoring device for subepithelial lesions. So again, you mark. You can go in, then you deploy this needle and these flanges that go inside of it, hoping to grab it and pull it inside, because it's hard to actually grasp these with an alligator or with a rat tooth. And again, you pull it in, and the goal is to get it all inside. So again, given its size limitations, you can only pull in so much and then resect it. So looking at adverse events, and this is where the serious discussion needs to be with the patients, that overall, 2% of patients may require surgery as a result of adverse events. So it is a high-risk procedure, okay? So that's 2% is relatively high where they're gonna go to surgery. Bleeding. Immediate bleeding is usually treated endoscopically right away. It's usually not that difficult to do. Delayed bleeding can happen, and in this study, I mean, in this meta-analysis, up to 6% has some delayed bleeding. But again, by far, the majority are things that you can handle endoscopically, okay? So perforation is the biggest one. This was in the German registry. They had 2.5% perforation rate, okay? 18 were acute, or what? Two-thirds acute, maybe, or a third were secondary, meaning delayed perforations, okay? So if it's an acute perforation, what they realize is probably it's because the sequence of events to deploy the device in the resection weren't maybe followed to the T. And you'll probably see this when you do the hands-on. There's a white rubber that moves. And basically, when you deploy this, you got to make sure the clip is completely deployed. Otherwise, if it's not completely deployed and you're cutting, then you're not cutting entirely above the closure device, and the closure device hasn't actually completed its seal of the wall, and so you can get a perforation. So there's this white ring that moves. You got to make sure it's completely gone before you do your cutting. Now, secondary perforations, those are delayed perforations. Unclear why, but, you know, some people think maybe it's a thermal injury. If you've had to go back and do more resection, smoking, some people think it may affect it if patients are immunosuppressed, body habitus, things like that, but secondary perforations, if they do happen and, you know, it's like a target set in a way that this is a delayed perforation, those probably need surgery. So this is a case, a 78-year-old male, past medical history of diabetes, hypertension. He was deemed to be a poor surgical candidate at the time. He underwent a screen colonoscopy. He had an 8-millimeter pop in the empyocenital orifice. They did a cold snare, and it showed high-grade dysplasia, and at the same time, they saw an 18-millimeter mass in the rectum, and the biopsy showed invasive adenocarcinoma. So he was referred for a rectal EUS. So he did a colonoscopy. There's a polyp, and you can see once we avert, you know, suction it in, as demonstrated, the appendix, you know, it comes back in. You can see there is, over here, this is adenoma. It probably goes into the lumen. Again, hard to decide how far it goes in, and then this was the rectal mass over here. Did an EUS. Here it looked clean, but then the more I looked at it, there was some concern. Does it extend to the musculoskeletal probe here? Does it not? To me, it was clearly into the submucosa, which basically means that it's not a good candidate for what you call curative ESD, although we learned today, thanks to Jason, there is no curative ESD intent, right? It's staging. This patient, to me, was not a good candidate because, again, he's going to need new adjuvant. He's going to need surgery, but the surgeon said, you know, it's a high risk. I'd rather not. Got an MRI to prove it, and the MRI kind of confirmed that it probably does extend into the musculoskeletal probria. And so, again, more images kind of says that. So after a long discussion with the surgeon by my side, and basically we said, well, we'll treat this, and then maybe new adjuvant therapy. So I did not have my own recording, so I got it on YouTube. So this was a live demonstration, 2019. Raj was there, and we demonstrated this device. So I'm just going to go to the relevant portions here. And it's used for marking. It comes with it. It also comes with a... So that was the marking device. 50 millimeter alligator rat tooth right here. That you can maybe see. So that's just to grab the tissue, I mean, the mass, and pull it inside, okay? And then the device itself has several components. So the main one, obviously, is this one. Lathe? Can you turn on the room lights? It might help us see better. Yeah, yes, that's a good idea. We're going, no, up, all the way up, please. I think that's all, yep. Much better, thank you. Okay, even I can see now. So this is the device, as you can see here. It has this sheath that, through it, runs the snare. I'm sorry, this is the snare. And then this snare comes on the inside, three millimeters from the tip. And it's a monofilament snare. So once the, and this is 23 centimeter depth. I'm sorry, okay, there you go. 23 millimeter depth, I'm sorry. And the inner lumen diameter is about 14 millimeters. So once you pull the polyp or the lesion inside, all the way in, you deploy it. It's like over the scope clip. Once you deploy it, now you've secured the muscularis propria side. Then the snare, which is, again, three millimeters from the tip. You close it, so you deploy it with this device, just like the over the scope clip device. You rotate it, and it deploys the over scope clip. It deploys it, and then you've got a handle here that you can then snug the lesion once you feel it snug and tight. Then you press on the yellow pedal, and then you cut. I'm gonna show you the pandaceal orifice one. Actually, pull the wire, if you don't mind, Jasmine, pull the wire back. Yep, I don't want it in the way. I accidentally, you know, coming in or something. Okay, good, thank you. Okay, all right, so we're gonna, we're just gonna go over the steps rows. We're gonna grab it, pull it in, and then once we feel it's pulled in, we're gonna deploy, and then we're gonna cut. And are you grounded? And everything's. You guys can see it, maybe? There's a marking there. Just gonna keep bringing this in. Nice job. Bringing it in. You gotta do it slow, you gotta take your time. This is not just something you grab in. Sometimes you just, you just need time. And I'm gonna advance my scope a little bit. Kind of get in there. You gotta be very patient when you do this. Just take your time. Okay, and then I'm gonna pull on it again, okay? So. There's the white band that I was talking about, right there. This is a little bit like the equivalent of your suction time on band ligation. Obviously, the more you pull this in, obviously the larger circumference you're gonna get, so. Yep, so I think I'm good there. So, how does the audience feel? And the panel, more, or this is good? Nobody's saying anything? Everyone's literally spellbound. It's easier to be right if you say nothing. So it's better to say nothing and be right afterwards. Yeah. Okay, so I think I'm as good as it's gonna get. I think I'm in all the way, okay? So, Rose, are you ready? That was rushed, me talking. I'm gonna, yep, one second. Ready? We're gonna deploy the clip. Okay, it's deployed. You can see the white band disappeared. Take this off, Rose. And snug it, please. Close it, yes, please, close. Close it, please, Rose. Okay, that's good, yep. Yep, yep, connect it. So we do the connection last so we don't accidentally cut. That's important. So right now, he's cutting the snare above the clip. Yep. I'm gonna cut, yep, ready? No, go, quickly, go. And that cutting wire is in that metal sheet that you see on the outside. There it is. Okay, so let me push this out a little bit more. And. So we have closure, obviously. Okay, good. Okay? There you go. Now, for the sake of time, I'm gonna go to the colon one. I'm just gonna show you the relevant part. So there is a device called a ClearCap that comes that you could purchase, that's 25 bucks. Is that it? So it's a dummy that you can use to assess if the lesion will come into the, before you actually open the whole device. So this is a dummy one. And this is a very useful thing, is rotating the patient, especially if you do an EMR, if you have a bleed, and it's in a. So it's a dummy one. It's very tempting just to suction it in. So here we are, just making sure that actually fits the device and that we can actually get the whole lesion in. I can see my markings on the right side. I think this is coming in nicely. I think I'm gonna give it a go. Okay. So this was against, not against necessarily, but the panel at the time did not think it was gonna work. But because of this dummy, we were able to kind of show that it was likely going to work. And so here we are. Not happy with this, I think. Oh, I'm sorry, 34. Sorry, I'm stopping you from lunch, maybe. So you can see it's- Oh, so Dr. Magner, our surgeon is here. So it's a big lesion, but again, because it was so pliable and easy to come, it worked. And so then, almost to the end, 48, 50. Okay, here we go. I'd like, I need to get more in. I'm not happy with this. So I'm gonna just wait a little bit and just try to get more in, more in. I'm gonna section a little bit. It would be okay. This is just boring to watch, but I just want you to watch to understand this is not something you're just gonna grab and cut. You really have to take your time if you're gonna do this and do it right. You have to be patient. You can't just yank on it. Just wait, slowly, wait, wait. Slow, slow. What I can do. How does the panel feel? Yeah, you're up to your lens. That's pretty good. Everybody's holding their breath. Okay, so here we go. Rosa, you ready? Go ahead then, okay. One second. Okay, I'm deploying. Okay, Rose, go ahead. You see, once it deployed, it went away. Go ahead. So again, things you have to be careful about. You're hot? I'm sorry? No, close, no. Close? Yes. Ready, Rose? Okay, go, cut. Okay. And we cut it and we actually then pinned it down and we were able to see all the margins and we got it all out. Okay. And then we went back in. And you can see the lesion there. No, I think this looks good. So. That's all I have for this. So basically, you'll get your chance to learn this today but the key is selecting the right lesion for this device and taking your time when you're doing it. Doing it in a very stepful, mindful manner because it's kind of almost a one and done. Now luckily, there are devices to take it out but remember, you've already deployed it under the muscle layer. So it's not superficial. So with that, I went over by three and a half minutes so I apologize and thank you for your attention. Thank you.

endoscopic full-thickness resection

over-the-scope clip device

technique

safety

effectiveness

patient selection

gastrointestinal lesions