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Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial.

Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial.
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Kato S, Kuwatani M, Sugiura R, Sano I, Kawakubo K, Ono K, Sakamoto N,


Kato S, Kuwatani M, Sugiura R, Sano I, Kawakubo K, Ono K, Sakamoto N, (click to view)

Kato S, Kuwatani M, Sugiura R, Sano I, Kawakubo K, Ono K, Sakamoto N,

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BMJ open 2017 08 117(8) e017160 doi 10.1136/bmjopen-2017-017160
Abstract
INTRODUCTION
The effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture.

METHODS AND ANALYSIS
We designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95% confidence intervals (CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method.

ETHICS AND DISSEMINATION
This study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016-0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER
The University Hospital Medical Information Network ID: UMIN000025727 Pre-results.

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