Clinical Trial in diagnosis of biliary stricture

JRCT ID: jRCT1052200051

Registered date:07/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary tract neoplasms
• Date of first enrollment: 01/12/2020
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 B: Direct insersoin of a biopsy forceps

Outcome(s)

• Primary Outcome: Rate of three consecutive success of biopsy within 5 minutes each using the assigned device
• Secondary Outcome: Time required 3 biopsies, Rate of appropriate biopsy specimens, Adverse events.

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Uza Norimitsu