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
- Interventions
- Device: Non-expandable plastic stent (plastic endoprosthesis)Device: Covered self-expandable metal stent (cSEMS)
- 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
- Arm && Interventions
Group Intervention Description study group NEPS Non-expandable plastic stent (plastic endoprosthesis) implantation of multiple non-expandable plastic stents group cSEMS Covered self-expandable metal stent (cSEMS) implantation of a self-expandable metal stent (cSEMS)
- 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 Milano
🇮🇹Milano, Italy
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
🇩🇪Essen, Germany
University of Helsinki
🇫🇮Helsinki, Finland
Department of Internal Medicine I
🇩🇪Frankfurt, Germany