A randomized controlled study of the usefulness of a novel device delivery system in the diagnosis of biliary stricture

Not Applicable

Recruiting

• Conditions: Biliary stricture

• Registration Number: JPRN-jRCT1052220103
• Lead Sponsor: za Norimitsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Patients with biliary stricture requiring histopathological diagnosis by ERCP.
-Patients who can undergo a transpapillary bile duct approach using a lateral endoscope.
-Patients over 20 years of age who have been fully informed about the study and who have given their free and voluntary written consent with sufficient understanding.

Exclusion Criteria

-Cases in which a histopathological diagnosis of biliary stricture lesion has already been made.
-Patients in poor general condition with impaired cardiac, respiratory, or swallowing functions that make ERCP difficult to perform.
-Cases of reconstructed intestinal tract after bile duct jejunal anastomosis, Billroth II reconstruction, and Roux-en-Y reconstruction except for Billroth I.
-Patients scheduled for POCS biopsy of bile duct stenosis (POCS after biopsy with an allocation device is acceptable).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of 3 successful biopsies within 5 minutes per biopsy using the novel device delivery system