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BMJ Open. 2017 Aug 11;7(8):e017160. doi: 10.1136/bmjopen-2017-017160.

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.

Author information

1
Department of Gastroenterology and Hepatology, Hokkaido University Faculty of Medicine and Graduate School of Medicine, Sapporo, Japan.
2
Department of Biostatics, Hokkaido University Faculty of Medicine and Graduate School of Medicine, Sapporo, Japan.

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.

KEYWORDS:

endoscopy; gastroenterology; hepatobiliary disease; pancreatic disease

PMID:
28801436
PMCID:
PMC5724077
DOI:
10.1136/bmjopen-2017-017160
[Indexed for MEDLINE]
Free PMC Article

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