Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Soon Chun Hyang University

Status: Completed

Conditions: Choledocholithiasis; Bile Duct Stricture

Treatments: Device: Direct peroral cholangioscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02276157

2014-07-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

92 participants in 2 patient groups

MB group

Experimental group

Description:

Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Treatment:

Device: Direct peroral cholangioscopy

Conventional group

Active Comparator group

Description:

Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Treatment:

Device: Direct peroral cholangioscopy