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AuthorMeng W.
AuthorLeung J.W.
AuthorZhang K.
AuthorZhou W.
AuthorWang Z.
AuthorZhang L.
AuthorSun H.
AuthorXue P.
AuthorLiu W.
AuthorWang Q.
AuthorZhang J.
AuthorWang X.
AuthorWang M.
AuthorShao Y.
AuthorCai K.
AuthorHou S.
AuthorLi Q.
AuthorZhang L.
AuthorZhu K.
AuthorYue P.
AuthorWang H.
AuthorZhang M.
AuthorSun X.
AuthorYang Z.
AuthorTao J.
AuthorWen Z.
AuthorWang Q.
AuthorChen B.
AuthorShao Q.
AuthorZhao M.
AuthorZhang R.
AuthorJiang T.
AuthorLiu K.
AuthorZhang L.
AuthorChen K.
AuthorZhu X.
AuthorZhang H.
AuthorMiao L.
AuthorWang Z.
AuthorLi J.
AuthorYan X.
AuthorWang F.
AuthorZhang L.
AuthorSuzuki A.
AuthorTanaka K.
AuthorNur U.
AuthorWeiderpass E.
AuthorLi X.
Available date2020-03-18T10:47:16Z
Publication Date2019
Publication NameThe Lancet Gastroenterology and Hepatology
AbstractBackground Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones. Methods We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with, number NCT02510495, and is complete.
SponsorThis study was supported by the National Natural Science Foundation of China ( 31570509 ) and Gansu Competitive Foundation Projects for Technology Development and Innovation ( 2018ZX-08 ). There was no commercial support. The authors thank Qiong Li, Yanni Ma, Hongxia Xu, and Xiyan Wang for their assistance with endoscopic retrograde cholangiopancreatography. We also thank Zhenzhen Wang, Dan Xu, Jingze Zhang, and Haiying Yu for assistance with data extraction and input, and Liang Qiao (Westmead Hospital, University of Sydney, Sydney, NSW, Australia), Jiankang Liu (Brigham and Women's Hospital of Harvard Medical School, Boston, MA, USA), and Weichih Liao (the National Taiwan University College of Medicine, Taipei, Taiwan) for scientific analysis and statistical review. We thank Xiaolong Qi, chairman of CHESS and director of the CHESS Center (First Hospital of Lanzhou University, Lanzhou, China) for the important advice and recommendations.
PublisherElsevier Ltd
TitleOptimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial
Issue Number6
Volume Number4

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