Clinical Trial in diagnosis of biliary stricture

Randomized controlled trial evaluating usefulness of new devices in the diagnosis of biliary strictures

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1052200051

Enrollment

Registered

2020-09-07

Start date

2020-12-01

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 tract neoplasms

Interventions

arm A: The new device is inserted through the guide wire into the bile duct under fluoroscopy. After exchange of the guide wire for biopsy forceps, tissue sampling is performed via the new device. arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with biliary structures requiring histopathological diagnosis by ERCP. 2.Patients with transpapillary bile duct approach using side-viewing endoscope. 3.Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients already diagnosed histopathologically. 2. Patients with surgical anatomy. 3. Patients fail to deep biliary cannulation. 4. Patients who have already undergone EST. 5. Patients deemed inappropriate by investigators (such as high-risk patients with acute pancreatitis).

Design outcomes

Primary

Measure	Time frame
Rate of three consecutive success of biopsy within 5 minutes each using the assigned device	—

Secondary

Measure	Time frame
Time required 3 biopsies, Rate of appropriate biopsy specimens, Adverse events.	—

Contacts

Public ContactHirokazu okada

Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University

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

Outcome results

None listed

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