Reply to Phillpotts and Webster
We would like to thank Drs. Phillpotts and Webster for their interest and comments on our study “Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial” .
The concerns raised by Drs. Phillpotts and Webster are as follows: endoscopic sphincterotomy (EST) as a control group, a high rate of prior endoscopic retrograde cholangiopancreatographies (ERCPs) without EST, a small number of enrolled patients per center, and post-ERCP pancreatitis (PEP).
Firstly, endoscopic papillary large balloon dilation (EPLBD) is now widely used in clinical practice and is recommended in the European Society of Gastrointestinal Endoscopy (ESGE) guidelines published in 2019 , and the Japan Gastroenterological Endoscopy Society (JGES) guidelines published in 2018 . However, our study cohort were enrolled between 2013 and 2015, and EPLBD for large bile duct stones was not established as a standard-of-care procedure at that time. Therefore, we chose EST as a control group in this study.
Secondly, patients who had cholangitis or who needed a bridging therapy owing to antithrombotic agents underwent biliary drainage first and were then enrolled in our trial if applicable. If EST with biliary stent placement was performed at the initial session, patients were not enrolled. As a result, the rate of prior ERCPs was high and enrollment per center during the study period was limited.
Finally, we agree that PEP is still a concern for EPLBD without EST. However, in our study, the rates of PEP in EPLBD without EST vs. EST were 4.7 % vs. 5.9 % in the total cohort and 2.0 % vs. 9.3 % in the subgroup without a prior ERCP, respectively. In four randomized controlled trials (RCTs) evaluating EPLBD with and without EST, the rate of PEP in EPLBD without EST was lower in two studies   (7.1 % vs. 11.4 % and 1 % vs. 3 %, respectively), equal in one study  (2.4 % vs. 2.4 %), and higher in only one study  (6.5 % vs. 4.3 %), with no significant differences reported in any of the four studies. The rate of PEP in our study appeared high in the aged cohort with a dilated common bile duct, but the rate of PEP in the four RCTs varied from 1.0 % to 11.4 %, so an interstudy comparison of PEP was difficult. In summary, though we agree that more data are necessary, the current data, including our study, support the use of EPLBD without EST as a treatment option for large bile duct stones, especially in patients with coagulopathy.
22 April 2021 (online)
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