A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer.
Not Applicable
- Conditions
- biliary obstruction from unresectable pancreatic cancer
- Registration Number
- JPRN-UMIN000004044
- Lead Sponsor
- Fourth Department of Internal Medicine, Sapporo medical university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1. Performance status is 4. 2. Japan Coma Scale (JCS) >=I-1. 3. Severe heart disease. 4. Severe lung disease. 5. PT INR >= 1.5. 6. Plt =< 50,000 mm3. 7. Patients who can not discontinue anticoagulant or antiplatelet drugs. 8. Age is lower than 20 years. 9. Patients with history of insertion of biliay stent which is larger bore than 8 Fr. 10. Patients with history of previous endoscopic sphincterotomy. 11. Patients with Billroth II or Roux-en-Y reconstruction after gastrectomy. 12. Patients with pancreaticobiliary maljunction. 13. Patients with distal intestinal obstruction from ampulla of Vater. 14. Patients considered ineligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method early complications rate (within 30 days following c-SEMS placement)
- Secondary Outcome Measures
Name Time Method 1. dulation of endoscopy 2. success rate of c-SEMS placement and and drainage 3. late complicaions rate (from 30 days to stent replacement or detah) 4. patency dulation of c-SEMS 5. cause of c-SEMS obstruction