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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
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| Title: | 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 |
| Authors: | Kato, Shin Browse this author | | Kuwatani, Masaki Browse this author →KAKEN DB | | Sugiura, Ryo Browse this author | | Sano, Itsuki Browse this author | | Kawakubo, Kazumichi Browse this author →KAKEN DB | | Ono, Kota Browse this author →KAKEN DB | | Sakamoto, Naoya Browse this author →KAKEN DB |
| Issue Date: | Aug-2017 |
| Publisher: | BMJ Publishing Group |
| Journal Title: | BMJ Open |
| Volume: | 7 |
| Issue: | 8 |
| Start Page: | e017160 |
| Publisher 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 naive 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. |
| Rights: | http://creativecommons.org/licenses/by-nc/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/67883 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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Submitter: 桒谷 将城
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