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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1052220103

Registered date:07/10/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBiliary stricture
Date of first enrollment04/01/2023
Target sample size260
Countries of recruitment
Study typeInterventional
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 OutcomePercentage of 3 successful biopsies within 5 minutes per biopsy using the novel device delivery system
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Tomoaki Matsumori
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan Kyoto Japan 606-8507
Telephone +81-75-751-4319
E-mail tom.matu@kuhp.kyoto-u.ac.jp
Affiliation Kyoto Univesity Hospital
Scientific contact
Name Matsumori Tomoaki
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan Kyoto Japan 606-8507
Telephone +81-75-751-4319
E-mail tom.matu@kuhp.kyoto-u.ac.jp
Affiliation Kyoto Univesity Hospital