This is going to be a pre-recorded video by Takao Itoi. Because of time constraints, Takao couldn't be with us at this time or the time zone change, but he's an excellent, excellent speaker. He's well-known throughout the world, again, like most of our panel discussants, has expertise in ERCP and therapeutic endoscopic ultrasound. He's at Tokyo Medical University, and he's going to do a talk today on balloon sphinctroplasty, with and without biliary sphincterotomy. Is there any danger? So go ahead and start his presentation, please. Hello, everyone. I'm Takao Itoi in Tokyo Medical University. First of all, I'd like to express my sincere gratitude to Professor Todd Bellon and Professor Nagishio Reddy and all organized committee for giving me this wonderful opportunity. In this session, I'd like to talk on the balloon sphinctroplasty with and without biliary sphincterotomy. As you know, EST has been developed in 1973 by Professor Kawai Kurasen and So Ma as a novel technique to extract the vireduct stones. Nowadays, it becomes gold standard for removal of vireduct stones. However, as Professor Peter Cotton mentioned, EST is the most dangerous procedure routinely performed by endoscopists. I totally agree with him. It may take a bit long time for beginners of EST to learn how to perform it safely to avoid adverse events. On the other hand, EPBD has been developed in 1982 by Professor Sturridge. This is its paper. Surprisingly, they inflate the balloon up to 15 mm in diameter. It means popularly large balloon dilation now, what is now called the EPLBD. Moreover, at this moment, there was no procedure-related complications, even using a large balloon. As you can see, in general, EPLBD, I mean large balloon dilation, has been introduced in 2003 by Professor Ersatz. Original concept of EPLBD is EST plus large balloon dilation from difficult stones only by conventional EST. Theoretically, risk of perforation or bleeding would be reduced by performing a less than maximal EST, and risk of pancreatitis from balloon dilation would be reduced by first separating the biliary and pancreatic orifice with EST. By the way, the term EPLBD includes three techniques, large balloon dilation after EST in one session, and large balloon dilation alone. In the large balloon dilation group, there is one group in which EST is intentionally not performed, and the other is in which EST is not necessary because of prior EST. Here you can see the popular opening technique. Apart from EST, balloon sphincter porosity is divided into mainly two types, namely less than 10 mm in diameter small balloon or more than 12 mm in diameter large balloon. Regarding small balloon, temporarily we named conventional EPLBD without EST and ESBD with EST. In terms of large balloon, we named EPLBD without EST and ESLBD with EST. You can see in the slide, major adverse events, namely bleeding, perforation, and pancreatitis may happen during procedure. Bleeding is caused by large EST, wrong direction EST, and large balloon dilation. Perforation is caused by large EST, wrong direction EST, large balloon dilation of biliary structure, and overall large balloon dilation more than diameter of common bile duct. Moreover, there are a lot of risk factors of pancreatitis, for example, PD opacification, pipillary edema due to difficult convection, EPLBD, small EST, etc., and also misinsertion cause pancreatitis. Based on the procedure, there are various pros and cons in each procedure, although we are not sure of each evidence in each technique. Although there has been a lot of study on the balloon sphincteroplasty, including randomized control trial, we are not sure whether it is safely performed or not. Anatomically, orifice of bile duct is narrow, and pancreatic duct orifice is very close to biliary duct orifice. So balloon dilation, in particular, large balloon dilation may cause not only bleeding or perforation of bile duct, but also the obstruction of PD orifice, leading to pancreatitis. So I'd like to show the EPBD, original EPBD, I mean small balloon dilation without EST. The patient had a liver cirrhosis, that's why we couldn't perform EST. So using a standard catheter, injection catheter, firstly, and using a contrast medium, firstly we confirmed stone. You can see a small stone in the bile duct, and a guide wire in place, and over the guide wire, small balloon, 10mm balloon, was inserted into the bile duct, carefully, and they gradually inflated. At this moment, we recognized a relatively large, long narrow distal segment, and a relatively hard, and gradually, about 1 minute, at least 1 minute dilation, then gradually deflation. You can see very nicely the opening of the bile duct, and without bleeding. Good for the small stone. And conditionally, I love basket compared to balloon. And finally, you can see a stone came out of bile duct. It was a nice case. Here you can see the short-term adverse event outcome of randomized control trial between EST versus conventional EPBD. Of 11 RCT studies, 4 studies, about 36.04% described that EPBD was risk factor of post-ELCP pancreatitis compared to EST alone, but there was no statistical significance in other adverse events. As I mentioned, since post-ELCP pancreatitis is caused by various factors, so far, conventional EPBD may be a good indication for special cases, like liver cirrhosis patient, patient taking antibiotic drugs, antithrombotic drugs, and surgical altered anatomy, like bilose 2 gastrectomy, or lumen-wide reconstruction. As a common technique, in particular, junior doctors use small balloon dilation with EST technique. For difficult EST case, I'd like to show the so-called ESBD movie. In this case, the major papilla was located in the third portion of the duodenum, and the calibration is a bit difficult. Fortunately, the standard catheter was inserted deeply in the bile duct, and then firstly, we performed the EST. But for the junior doctor, EST is not easy, was not easy due to the location of the papilla, and you can see we suspected a relatively long narrow distal segment. Maybe it's enough to remove the stone, but for safe, my junior used a small balloon. The maximum size of balloon was 8 mm in diameter. I guess it was enough to remove the stone, and the depression. Comparing with the EST alone, we got a relatively large bile duct orifice, and the bile flow easily seen. And using basket, the very small stone in the lower bile duct, distal bile duct, removed safely and without any complication after this. So one retrospective study from Japan described that ESBD may be safely performed. I guess in order to overcome post-ELCP pancreatitis by conventional EPBD, minimal EST followed by small balloon dilation may be one of option. So how about conventional EPRBD plus EST, so-called ESLBD? I'd like to show the movie of ESLBD. The patient had a large bile duct stone. You can see a very large bile duct diameter and a huge stone. Firstly, we performed EST, but unknown papillary loop. That's why, so small EST plus large balloon dilation, carefully and gradually dilation. And finally, you can see a very nicely opening of the bile duct orifice up to 80 mm in diameter. And for safe, we frequently use mechanical resorptive tine in such a large bile duct stone, huge bile duct stone. And finally, we crush the stone and one by one remove. Even crush stone, one piece was huge, very big, and easy extraction. There was no stone. So here you can see the short-term adverse event outcome of RCT between EST versus ESLBD. The adverse event outcome of ESLBD was similar to those of EST, except one study on the cholangitis. Based on those results, ESLBD is safely performed as well as EST. So the question is how about EPLBD alone? I mean large balloon dilation without EST. Here you can see the short-term outcome of 4 RCTs. Surprisingly, they showed large balloon dilation without EST can be safely performed as well as large balloon dilation with balloon. Based on those results, whether EST is ad or not depends on the endoscopist's preference. Of course, I always do EST, except difficult cases. Last year, one RCT study on the EST versus EPLBD alone published from Japan. It showed that large balloon dilation without EST is similarly effective and safe to EST. Professor James Rao mentioned in the editorial of this paper that large balloon dilation is legitimate and acceptable solution, like bilose 2 gastrectomy, RUNY, and coagulopathy, but do not inflate the balloon beyond the size of lower valve diameter to avoid unnecessary adverse event. So ladies and gentlemen, my conclusion. Conventional EPLBD may be able to occur the post-ELCB pancreatitis. Although, the mechanism of post-ELCB pancreatitis due to balloon sphincter plasticity is not correctly solved. Large balloon dilation regardless of prior EST is safely performed. Prior EST followed by large balloon dilation depends on the endoscopist's preference. Also, EST plus large balloon dilation is original technique. Minimal EST followed by small balloon dilation may be safe and better technique even in non-difficult stone cases for non-secured ELCB endoscopist than moderate or large EST which causes adverse events like bleeding or perforation. Thank you very much. Thank you for your kind attention.

Takao Itoi

ERCP

therapeutic endoscopic ultrasound

balloon sphincteroplasty

biliary sphincterotomy