JPRN-UMIN000004044Completed未知
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. - A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.
Fourth Department of Internal Medicine, Sapporo medical university0 sites200 target enrollmentStarted: August 16, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
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.
Investigators
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