Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Not Applicable
- Conditions
- Benign biliary stricture and benign pancreatic stricture
- Registration Number
- JPRN-UMIN000022164
- Lead Sponsor
- Graduate School of Medicine, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with difficulty in endoscopic approach to strictures. 2. Patients withpossibility of malignant biliary or pancreatic stricture. 3. Patients with performance status 3-4. 4. Patients with serious concomitant diseases such as heart failure, respiratory failure, or disturbance of consciousness and who cannot tolerate endoscopic procedures. 5. Patients considered ineligible by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of stricture resolution at stent removal after 90 days of indwelling.
- Secondary Outcome Measures
Name Time Method 1.Overall rate of stricture resolution at the end of the study period. 2.Rate of stricture recurrence and period until stricture recurrence. 3.Success rate of stent removal. 4.Adverse event at stent removal. 5.Other adverse events.