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

Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393067

Enrollment

Registered

2011-07-13

Start date

2011-03-31

Completion date

2015-03-31

Last updated

2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Keywords

cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation

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.

Interventions

DEVICENon-expandable plastic stent (plastic endoprosthesis)

plastic stent (plastic endoprosthesis)

DEVICECovered self-expandable metal stent (cSEMS)

Removable, covered self-expandable metal stent (cSEMS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* post-OLT stenosis of the bilio-biliary anastomotic

Exclusion criteria

* non-anastomotic stricture * stent implatation technically not feasible

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Occurence and severity of complications related to the endoscopic procedures	up to 2 months after ERCP

Countries

Finland, Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026