All right, so let's try and cover EDGE, also known as GATE, and now that we have a little more time, I'll hopefully go through this nice and slowly. EDGE stands for EUS-Directed Gastro-Gastrostomy for ERCP, but as we know, this access can be used not only for ERCP, but any kind of endoscopic intervention. This is my disclosure slide. So basically, this came around with the need for doing ERCP in Roux-en-Y gastric bypass patients. And the first two approaches that were around enteroscopy-associated ERCP has the obvious advantage of no need to reverse the gastric bypass, so you keep the patient's anatomy intact. But the disadvantage is the technical success can vary from 60% to 95% depending on the combined limb length. And it's also challenging to do fairly complex pancreatic or biliary work with a double balloon endoscope. So surgical-assisted ERCP seemed to overcome this issue in that the technical success is very high, but there is an operation that's associated with it and the pain that comes with surgery. And I cannot tell you the pain that comes to us from scheduling. It is extraordinarily cumbersome to do an operative ERCP. And then reaccess can be a challenge if you need to go back in for bleeding, leaks, etc. So EDGE seemed to overcome both these two challenges with very high technical success rates, but it has its own challenges. There is certainly a second procedure you need to do to remove that luminoposing stent. The initial concerns for weight gain, ulcers, and acid reflux-related problems can be fairly easily mitigated if you tell a patient to stick to their gastric bypass diet, stay on a PPI. But the problem that we may not have an answer yet for is what is this true rate of chronic fistulas that we're going to create by going gastro-gastric? Now I've put up these three options here, but unquestionably, there is a fourth and a fifth option. You can certainly go trans-abdominal through a gastrostomy and do an ERCP, but that is uncomfortable and inconvenient with a much larger access point in the abdomen. And of course, there is EUS hepatic gastrostomy or entro-hepatic gastrostomy to be able to access the bile ducts either through the small bowel or the stomach. So this was our paper in 2011, looking at lap-assisted ERCP with balloon-assisted ERCP. And this is where we came up with that number of over 150 centimeters of combined limb length, where our success rate for balloon-assisted ERCP tended to drop. So EDGE was first described in 2014 by Michelle Kahela with the statement of game over. And I'm fairly sure he meant it more as a question, is this truly game over and our only access point? And as most of us who do this have certainly encountered one of the biggest challenges and scary parts of doing an EDGE, which is dislodging the limbs. And so this is a quick video of a case of a patient that had actually not an ERCP indication, but a high-grade duodenal stricture that could not be reached with a balloon-assisted ERCP. And we decided to try and access that point with an endoscopy and creating a gastro-gastrostomy, which we did. And now this is us going into the excluded stomach and there's the stricture. So good news, this was a benign duodenal stricture with an ulcer and a very large clot actually that was occluding the duodenal lumen. So I was happy with that outcome. Now on fluoroscopy, what you can see over here is my lumen opposing stent is not a very happy place. That's sitting in the excluded stomach over there. So no need to panic. You've outlined the stricture over here, which is what we're seeing on fluoroscopy. I left a guide wire in place. And now as you come back, this is what you're going to see. You may see some peritoneum and you can see some bleeding from the site that we had created. But again, this is not a reason to panic, just figure out what needs to come next. And in this situation, instead of wasting the $5,000 stent we've already deployed, we decided we'll pull this stent into the channel of our scope. And I'm going to try and use the endoscope itself as a delivery system. So carefully pulling back under fluoroscopy, pulling that excluded stomach up to the pouch, and then pulling my endoscope back till I can see the esophagus, and then releasing the stent allowed us to salvage this and not need a new stent. So what is the best way to prevent LAMS dislodgement? Hands down, the safest way is going to be if you do an ERCP or an endoscopy one to two weeks after stent deployment, and you have a nice mature fistula that even if you dislodge the LAMS, it's not going to be of any clinical consequence. Could a 20 millimeter luminoposing stent give you more space around your endoscope? Possibly. But for me, I think using a securing system to hold that luminoposing stent in place might be our safest option. So three years ago, Muin and I put together our initial experience with doing this, of using an over-the-scope clip or suturing the LAMS in place to prevent dislodgement. So this was our first case that I did a stone in the distal bile duct, and this is how the edge is being performed. So you can see the remnant stomach over here under EUS and the needle punctures perform because the space over there is a little too small right now to deploy a luminoposing stent. So we can inject contrast saline, fill up that excluded stomach, and now with a direct puncture, which is what we're doing, a 15 millimeter luminoposing stent was deployed into that excluded stomach. And you can see that stent wants to get pulled in over there. Now this is a 11 by 6T over-the-scope clip, which was used to secure this luminoposing stent in place. So just one clip holding the gastric pouch to the luminoposing stent. And after that, it can go down with a video duodenoscope, and you can see the amount of force that can sometimes be generated on the stent, making dislodgement fairly easy if you haven't secured it. So these were the stones removed, but now the patient comes back four weeks later for removal of this thing. And we did not have the over-the-scope removal device at this point. And we've taken out multiple over-the-scope clips by just cutting through them with APC. Let's go back. And in this situation, I burnt the granulation tissue holding it in place, and we were able to take it out. I got a little bit smarter after that difficulty of that first over-the-scope clip and said, you know what, we'll invest about five, seven minutes in stitching the stent in place. So this is your therapeutic endoscope being used to stitch that. A little bit of bleeding that you'll encounter with stitching is very common, but it stops quite spontaneously with cinching it. And this is what allows us to then do a more successful ERCP. Now coming back to remove the stent is so much easier once you have sutures instead of that over-the-scope clip. And just with an indoor scissor, you can cut the stitches, grab the lumen-opposing stent, and take it out. So I won't get into the details of the case series that have been done so far on EDGE, but just point out at least one of the comparative studies that looked at laparoscopic ERCP with EDGE. And as expected, the procedure times were much shorter with EDGE. The recovery was faster with something endoscopic. And what was interesting to see in this study was that 10% of the patients had to convert to an open surgery just to get access to that excluded stomach. And then, interestingly, what we found is most of these studies were finding people may actually be losing some weight after an EDGE rather than gaining weight. No great studies looking at really follow-up data on fistula closure. This one series looked at 19 patients which had one fistula did not close that needed endoscopic closure to close it finally. So what's the best approach to ERCP and Roux-en-Y gastric bypass? This is what we like to do. And this is what Ken Binmola outlined as well. Get everyone involved. This should be a multidisciplinary approach. Get the operative report so you know how long that combined Roux and diverted limb is. And involve the patient in this decision. We don't need to go through this entire chart. But if the patient does need a cholecystectomy, you can certainly consider at that point in time if they want to give us laparoscopic access. If they do not need a cholecystectomy, understand what you're trying to achieve. Is this complex work? What is the length of the combined limb? And is the patient willing and understand some of the uncertainties that are associated with an EDGE? Would they be willing to do that? So this is an example of what complex pancreatic ovulary work, which could be very challenging to do with just double balloons. So we've got an access, we've dilated, stitched the stent in place. And this was me trying to do a minor papilla access in a patient with relapsing pancreatitis, chronic pancreatitis. And as you can see, I'm in a very short scope position. And for those who remember yesterday's talk, you really need to be in a long position, which I could not get into to be able to, I keep skipping forward, to be able to get into the minor papilla. So this is us struggling to try and get into the minor papilla. But on EUS, once my scope is into the excluded stomach, we can do a pancreatic rendezvous, outline the distal pancreatic stricture, pass the guidewire. And I got a little bit excited with the guidewire way down into the jejunum, but then we were able to get in and do a minor sphincterotomy. And this is actually an attempt at a needle knife. You can see how far off I was with that attempt over there. And then go ahead and place the stent. I won't go much into this again. This is another term that's been used, EUS-guided gastrogastrostomy for non-ERCP interventions, which actually is the same as GATE. And this was a short case series where John Nassar and a few of us put together 13 patients to be able to drain Waldorf necrosis, to be able to treat malignant duodenal strictures. And we even had a case of a perforated gastric ulcer that was able to be closed via this access. So I want to end that talk by saying all of this complex stuff that we're doing with EUS-ERCP cannot be done without the help of amazing surgeons, your interventional radiologists. I've been fortunate to have a fantastic mentor in Dr. Kozerik. I don't know this guy. I know that dog. That's Elvis. And having friends around the world that support you, do research together with you. And of course, hands down, the most important, being able to have nurses that will stand by you through two and three hour long procedures and support you and say, hey, how about this? What do you want to try next? So with that, I'd like to end this talk and say thank you, everyone.

EDGE procedure

ERCP

endoscopic ultrasound-directed gastro-gastrostomy

Roux-en-Y gastric bypass surgery

multidisciplinary approach