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

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

Tomoaki Matsumori

Kyoto Univesity Hospital

54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan

tom.matu@kuhp.kyoto-u.ac.jp

Matsumori Tomoaki

Kyoto Univesity Hospital

54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan

+81-75-751-4319

tom.matu@kuhp.kyoto-u.ac.jp

Recruiting

Oct. 07, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

diagnostic purpose

-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.

-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).

Both

Biliary stricture

The device is assigned to the bile duct stricture biopsy at the time of ERC, and the biopsy is performed with the assigned device.

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

+81-75-366-7618

Sept. 12, 2022

No

none