Clinical Trial in diagnosis of biliary stricture
Phase 4
Recruiting
- Conditions
- Biliary tract neoplasms
- Registration Number
- JPRN-jRCT1052200051
- Lead Sponsor
- za Norimitsu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of three consecutive success of biopsy within 5 minutes each using the assigned device
- Secondary Outcome Measures
Name Time Method Time required 3 biopsies, Rate of appropriate biopsy specimens, Adverse events.