Hello everyone, my name is Prabdhin Chahal. I would like to thank ASGE and course directors Dr. Peter Dragunov, Asma Shaukat and James Buxbaum for giving me this opportunity. Next 10 minutes or so I'll try to convince you how you only need dilating balloons for management of majority of common bileduct stone cases. These are my disclosures. For any technology to be successful and effective, it needs to fulfill certain criteria, namely its applicability, ease of use, interoperability, how easily it can be integrated in the endoscopy unit, what are the adverse events associated with it, what kind of ecosystem impact does it leave, and what are the adoption and maintenance costs. When it comes to technology like dilating balloons, they fulfill all these criteria compared to their alternatives. As we all know, bileduct stones are seen in up to 12% of patients undergoing cholecystectomy. The good news is up to 90% of the bileduct stones can be managed with standard tools and techniques, including retrieval baskets or balloons. And it's only 5 to 7% of the stones, what we call as complicated stones, that require advanced tools and techniques for management. And on top of the list for these advanced tools and techniques is endoscopic papillary large balloon dilation. It was first reported in 1990, and then in 2003, Ursos reported this technique in conjunction with endoscopic sphindrotomy, whereby he was able to achieve clearance in 95% of the patients with the stone size measuring between 15 to 28 millimeters when the standard tools and techniques had failed. Since then, we have noticed over 12 RCTs and more than 5,500 patients treated successfully and safely with this technique. Now, there are certain practical tips that I would like to share with you about using this technique. The first and the most important one is choosing the right size balloon. The size of the balloon should be similar to the size of the distal common bileduct. You don't want to use a balloon that is bigger than the distal common bileduct. Of note, ESG recommends choosing a balloon size of 8 millimeters in combination with the ESTE, endoscopic sphindrotomy. Now, when you look at this fluoroscopic image, you can see the shaft of the duodenoscope, which is close to 13 millimeters, and the bileduct caliber is a little bit larger than that. But notice how the distal bileduct is a little bit narrowed and you see multiple faceted stones in the distal bileduct. The balloon is advanced over the wire and once it's straddled across the papillary orifice, which about halfway of it is jutting out of the papillary orifice, you gradually inflate the balloon with a dilute contrast till the waste is gone. Usually, it takes about 30 seconds. Personally, once the waste is effaced, I ask my assistant to deflate the balloon. Some people, they like to keep it inflated for about 60 to 120 seconds. Don't leave it longer than 180 seconds or three minutes. Why? Because the study published by Meng et al. in Lancet Gastroenterology and Hepatology reported increased incidence of post-CRCP pancreatitis when the balloons were left inflated for more than three minutes across the papillary orifice. If you notice a stone in the bileduct on fluoroscopy, those are the stones with high calcium content. And if you try to inflate the balloon next to the stone, there is a risk of bileduct wall injury. Don't inflate the balloon in those situations next to the stone. However, if you're dealing with a patient with soft cholesterol type stones, you can inflate it safely next to the stone and often helps with the fragmentation. Personally, I don't try to inflate it regardless of whether I'm seeing the stone on fluoro image or not. Needless to say, the sphindroplasty is preceded by submaximal endoscopic sphindrotomy. Try to avoid full sphindrotomy because there is reported risk of increased bleeding and perforation in patients who underwent full completion sphindrotomy prior to balloon sphindroplasty. Due to the plethora of research and data on the safety and efficacy, ASGE recommends performance of endoscopic sphindrotomy followed by large balloon dilation as the first step in management of complicated or large bileduct stones. And this is based on robust data. And in this table is the systematic review meta-analysis quoted by the ASGE guideline paper, whereby they showed endoscopic balloon dilation with sphindrotomy compared to endoscopic sphindrotomy alone outperformed in achieving stone clearance, need for mechanical lithotripsy, and adverse events. Similarly, our European sister society, ESGE, also recommends starting with limited sphindrotomy and endoscopic papillary large balloon dilation for management of complicated or difficult bileduct stones, whereby standard tools and techniques have failed. Some more data I would like to share with you. These are the three prospective randomized multi-center studies with the N in 70s and 80s. And the study design included comparing papillary large balloon dilation with sphindrotomy versus sphindrotomy alone for management of stones larger than 12 millimeter in size with the goal of achieving complete clearance at index ERCP and evaluating adverse events. Now, looking at the data pertaining to just the papillary balloon dilation alone, they noticed successful clearance at index ERCP in close to 90% of the patients with the adverse event ranging from 6 to 9%. Now, there are two head-to-head studies comparing endoscopic papillary large balloon dilation with cholangioscopy. I'm going to share with you one study, and I'm sure my colleague, Dr. Raj Shah, will perhaps share the other one. Now, this RCT, they randomized 100 patients, and the goal was to look at complete stone clearance spread over two ERCP. When compared to cholangioscopy, there was no statistical difference in achieving stone clearance during index ERCP and overall stone clearance after two ERCPs. In fact, the papillary group, the stone clearance rate was a little bit higher, although did not reach statistical significance. Adverse events were comparable, and the procedure time was significantly shorter for the papillary balloon dilation group, which, again, doesn't come across as any surprise. Of note, there was no difference in the number and size of stones across both groups. Now, this led to this systematic review meta-analysis published in CGH in 2021, where this study was included. This systematic review meta-analysis compared all the three different techniques, including mechanical lithotripsy, cholangioscopy, and endoscopic papillary large balloon dilation. The authors did note the limitations of the systematic review, namely moderate heterogeneity and lack of strict definition of what the difficult stone disease is. However, one of their top conclusions was that sphintrotomy followed by endoscopic papillary large balloon dilation provides an excellent, less expensive, and widely available option, especially for index ERCP, and I wholeheartedly agree with this assessment. What about the adoption and maintenance cost? We all know the cost of the dilating balloons, which is less than $200, and the cost of the disposable cholangioscope. In a study published by GBank Group in CGH 2020, they found that cholangioscopy procedure, the supply cost was significantly higher, namely $7,221 compared to papillary balloon dilation group, where the supply cost was $3,349. All of us who have the cholangioscope set up in our endo unit, we know it requires an elaborate setup, and there is a learning curve to use this technology really well. Some reported studies saying that you need to do at least about 25 procedures in order to be facile. And of course, when we are dealing with a disposable cholangioscope, it does leave a larger carbon footprint. So back to our original diagram. Does endoscopic papillary balloon dilation as a tool and technique satisfy all these criteria compared to its alternative, like cholangioscopy? I would say the answer is resounding yes. That being said, this is my final summary slide. What is my practice? If I'm dealing with a patient who has stone size one to two centimeter, I start with submaximal sphenotomy in conjunction with endoscopic papillary balloon dilation and may or may not proceed to mechanical lithotripsy if needed. If you have somebody with stone two to three centimeter in size, again, chances are you would need mechanical lithotripsy. And if this fails, or if the stone is larger than three centimeter in size, you proceed directly with cholangioscopy with EHL or laser lithotripsy. If you are not able to achieve complete clearance, don't forget to leave a plastic stent or a metal stent, a fully covered metal stent. There is significant literature reporting that plastic or fully covered metal stents by themselves as a standalone technique are able to achieve stone clearance in up to 60 to 80% of the patients. With that, I would like to conclude and thank you so much for giving me the opportunity.

Prabdhin Chahal

common bile duct stones

dilating balloons

endoscopic papillary large balloon dilation

choosing the right size balloon