Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Not Applicable

Completed

• Conditions: Bile Duct Stricture; Choledocholithiasis
• Interventions: Device: Direct peroral cholangioscopy

• Registration Number: NCT02276157
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

This study was aimed to to evaluate the efficacy of the new multibending ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC.

Detailed Description

Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, the investigators evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, which was defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 min.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-28
• Primary Completion: 2017-01
• Study Completion: 2017-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• biliary disease requiring diagnostic and/or therapeutic direct POC
• distal common bile duct (CBD) dilation > 8 mm
• previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP
• ability to provide informed consent

Exclusion Criteria

• presence of any contraindication to ERCP
• bleeding tendency (international normalized ratio > 1.5 or platelet count < 50,000/ mm3)
• diffuse stricture of the distal CBD
• diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV)
• altered gastrointestinal anatomy or significant duodenal obstruction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MB group	Direct peroral cholangioscopy	Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)
Conventional group	Direct peroral cholangioscopy	Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Primary Outcome Measures

Name	Time	Method
The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC	within 15 min after insertion of endoscope into the mouth	successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories

Secondary Outcome Measures

Name	Time	Method
Procedure time required for free-hand insertion	the time of oral intubation with the ultra-slim endoscope to the time of reaching the obstructed segment of the biliary tree or bifurcation, within 15 min after insertion of endoscope into the mouth	Procedure time required for free-hand insertion
The technical success of diagnostic and therapeutic interventions	Within 24 hours after Completion of DPOC	The technical success of diagnostic and therapeutic interventions
Adverse events related to direct POC	Within 7 days after DPOC	perforation, cholangitis, pancreatitis, and air embolism

Trial Locations

Locations (1)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of