The role of endoscopic papillary large balloon dilatation without sphincterotomy
We read with interest the article by Kogure et al. , which concluded that endoscopic papillary large balloon dilation (EPLBD), when compared to endoscopic sphincterotomy (EST) alone, achieves higher rates of complete stone removal without increasing adverse events. We compliment the authors on a methodical study; however, we suggest that the following observations are important to consider.
Patients included had large (> 10 mm) common bile duct (CBD) stones, with a third having calculi > 15 mm in size, in the setting of a dilated bile duct. European Society of Gastrointestinal Endoscopy (ESGE) guidance recommends EST followed by EPLBD in such large stones , and treatment with EST alone, as used in this study, would less commonly represent standard practice.
Over the 2-year study period, only 181 patients were enrolled at 19 institutions – representing five procedures annually per center. Mindful that approximately 50 % of endoscopic retrograde cholangiopancreatographies (ERCPs) are performed for CBD stones, we question how transferable the results are to a less selected population. Indeed, the study group were rather unique in that prior ERCP had been performed in 43 % of cases with no ampullary intervention, such as EST, having taken place. The authors have not expanded on this.
The authors conclude that there was a low rate of post-ERCP pancreatitis (4.7 % – 5.9 %). However, this is higher than the quoted rate (3.47 %) from a systematic review of ERCP complications ; particularly so in view of the relatively low risk population (over 60 years of age and with a dilated CBD). We are reminded of the randomized controlled study by Disario et al.  that found a significantly increased morbidity and even mortality rate in patients undergoing papillary balloon dilation without EST.
Although this study is well conducted, we would be cautious in advising a change of practice until such time as EPLBD without prior EST is shown to be as safe and effective as EPLBD following EST for patients with large CBD stones.
22 April 2021 (online)
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- 1 Kogure H, Kawahata S, Mukai T. et al. Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial. Endoscopy 2020; 52: 736-744
- 2 Manes G, Paspatis G, Aabakken L. et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2019; 51: 472-491
- 3 Andriulli A, Loperfido S, Napolitano G. et al. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781-1788
- 4 Disario JA, Freeman ML, Bjorkman DJ. et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004; 127: 1291-1299