cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
Not Applicable
Completed
- Conditions
- Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation
- Registration Number
- NCT01393067
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- Brief Summary
Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).
- Detailed Description
This is a multi-center randomised trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- post-OLT stenosis of the bilio-biliary anastomotic
Exclusion Criteria
- non-anastomotic stricture
- stent implatation technically not feasible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of interventions (ERCP) to attain resolution of stenosis up to one year Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS
- Secondary Outcome Measures
Name Time Method Occurence and severity of complications related to the endoscopic procedures up to 2 months after ERCP
Trial Locations
- Locations (4)
University of Helsinki
🇫🇮Helsinki, Finland
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
🇩🇪Essen, Germany
Department of Internal Medicine I
🇩🇪Frankfurt, Germany
University of Milano
🇮🇹Milano, Italy
University of Helsinki🇫🇮Helsinki, Finland