Response to “Comment on Study of Risk of pancreatitis following biliary stenting with/without endoscopic sphincterotomy” by Jia-su Li et al.

Abstract Background and study aims Endoscopic nasobiliary drainage (ENBD) for a malignant stricture in the bile duct has some advantages over endoscopic biliary stenting (EBS). However, ENBD may cause nasopharyngeal discomfort. We developed an external-to-internal convertible endoscopic biliary drainage (ETI-EBD) device that enables both internal and external drainage to occur during a single endoscopy. Patients and methods This device consists of three parts, comprising a 5-Fr ENBD tube (250 cm) (ENBD-t), an 8.5-Fr EBS tube (7 cm) (EBS-t), and an 8-Fr pusher tube for EBS (230 cm) (P-t). The EBS-t is mounted over the ENBD-t at the distal end of the ENBD-t. The P-t is also placed over the ENBD-t. After an endoscopic sphincterotomy, the EBS-t of the device is inserted into the papilla, then the duodenal endoscope is withdrawn, leaving the device in place. After ENBD, only the ENBD-t was withdrawn from the P-t. At this point, the EBS-t was isolated and left without endoscopy or radiography. Results ETI-EBD was successfully placed in all consecutive 21 patients (100 %). The release of EBS-t from ENBD-t wit was successfully completed in 19 patients (90.5 %). There were 4 patients with kink of P-t when exchanging this device from the mouth to the nose. It was difficult for 2 patients to withdraw the ENBD-t because of poor lubrication performance. There were no significant complications associated with the use of the device. Conclusion This device allows for both external and internal biliary drainage with a single endoscopy.

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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

BMJ Open ◽

10.1136/bmjopen-2017-017160 ◽

2017 ◽

Vol 7 (8) ◽

pp. e017160 ◽

Cited By ~ 3

Author(s):

Shin Kato ◽

Masaki Kuwatani ◽

Ryo Sugiura ◽

Itsuki Sano ◽

Kazumichi Kawakubo ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Biliary Drainage ◽

Endoscopic Sphincterotomy ◽

Biliary Stricture ◽

Controlled Trial ◽

University Hospital ◽

Biliary Stenting ◽

Endoscopic Retrograde ◽

Endoscopic Biliary Stenting ◽

Randomised Controlled

IntroductionThe 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 analysisWe 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 disseminationThis 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 numberThe University Hospital Medical Information Network ID: UMIN000025727 Pre-results.

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