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

JRCT ID: jRCT1052220103

Registered date:07/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary stricture
• Date of first enrollment: 04/01/2023
• Target sample size: 260
• Study type: Interventional
• Intervention(s): The device is assigned to the bile duct stricture biopsy at the time of ERC, and the biopsy is performed with the assigned device.

Outcome(s)

• Primary Outcome: Percentage of 3 successful biopsies within 5 minutes per biopsy using the novel device delivery system

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Uza Norimitsu