A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.
Phase 3
- Conditions
- Distal biliary obstruction caused by unresectable pancreatic cancer
- Registration Number
- JPRN-UMIN000016010
- Lead Sponsor
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
1)Prognosis will be within 30 days 2)Having post gastrectomy with Billoth II or Roux-en-Y reconstruction 3)After percutaneous biliary drainage 4)Having history of SEMS placement for biliary obstruction 5)Having active infectious disease except acute cholangitis 6)Having severe acute cholangitis according to Tokyo Guidelines 7)Patients with the allergy to metal 8)Pregnant women or those suspected of pregnancy 9)Patients considered ineligible by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to SEMS dysfunction
- Secondary Outcome Measures
Name Time Method Early(within 30 days after SEMS placement) and late complication, Overall survival, Bilirubin level decreasing rate, Total costs of SEMS-related interventions