Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial

We read with great interest the recent article by Kogure et al. on the MARVELOUS trial [1].

In this trial, the rate of single-session complete stone removal was significantly higher in the endoscopic papillary large balloon dilation (EPLBD)-alone group than in the endoscopic sphincterotomy (EST) group (90.7 % vs. 78.8 %; P = 0.04). The use of lithotripsy was significantly less frequent in the EPLBD group and the adverse event rates between the two groups were similar (9.3 % vs. 9.4 %). We agree with the authors conclusion that EPLBD alone, compared with EPLBD with EST, may increase the rate of complete stone removal in a single session, without increasing adverse events, and reduce the need for repeated endoscopic retrograde cholangiopancreatography (ERCP) interventions or lithotripsy; however, some points need to be clarified.

It is stated that patients with a previous history of ampullary intervention were excluded from the study, but the definition of the ampullary interventions needs to be clarified. If prior EST is one of the ampullary interventions, it means all patients in study had a naïve papilla. If not, then some of the patients had a previous EST, which means that they had re-EST or balloon dilation prior to study randomization. Previously performed EST procedures may cause late complications, such as orifice stenosis, fibrosis, and sphincterotomy-related biliary strictures, which may affect results. According to the data in Table 1, 41.9 % and 49.4 % of patients in the EPLBD and EST groups, respectively, had a prior ERCP. If any ampullary intervention, such as sphincterotomy, was performed in these patients, this will also affect the outcomes.

Another controversial issue is the length of the EST. We believe the authors should not ignore the possible risk of inadequate EST in reaching their successful end points and this matter should have been clearly discussed in the paper.

Publication History

Article published online:
27 January 2021

• References

• 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