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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1052220103

Enrollment

260

Registered

2022-10-07

Start date

2023-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary stricture

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

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

Contacts

Public ContactTomoaki Matsumori

Kyoto Univesity Hospital

tom.matu@kuhp.kyoto-u.ac.jp+81-75-751-4319

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026