cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

Johann Wolfgang Goethe University Hospital60 enrolled

Overview

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).

This is a multi-center randomised trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Interventions

Non-expandable plastic stent (plastic endoprosthesis)DEVICE

plastic stent (plastic endoprosthesis)

Covered self-expandable metal stent (cSEMS)DEVICE

Removable, covered self-expandable metal stent (cSEMS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * post-OLT stenosis of the bilio-biliary anastomotic Exclusion Criteria: * non-anastomotic stricture * stent implatation technically not feasible

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

Milan, Italy

Outcomes

Primary Outcomes

Number of interventions (ERCP) to attain resolution of stenosis

Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS

Time frame: up to one year

Secondary Outcomes

Occurence and severity of complications related to the endoscopic procedures

Time frame: up to 2 months after ERCP

Data from ClinicalTrials.gov

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