A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones
Phase 3
- Conditions
- bile duct stones, ductal stones
- Registration Number
- JPRN-UMIN000013887
- Lead Sponsor
- Kansai Endoscopic Device Selection (EDS) Working Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients who underwent reconstruction of upper digestive tract(Bil II or RY) 2. Patients who underwent EST or EPBD previously. 3. Performance status is 4. 4. ASA physical status is more than 3. 5. Patients who undergo hemodaialysis. 6. Judged as inadequate for this study by the investigator. 7. Patients who become serious after first procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) total time for removal of bile duct stones 2) total sessions of ERCP
- Secondary Outcome Measures
Name Time Method 1)early and late complication rates 2)recurrence rate