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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Treatments: Device: Covered self-expandable metal stent (cSEMS); Device: Non-expandable plastic stent (plastic endoprosthesis)

Study type: Interventional

Funder types: Other

Identifiers

NCT01393067

148/10

Details and patient eligibility

About

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).

Full description

This is a multi-center randomised trial.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-OLT stenosis of the bilio-biliary anastomotic

Exclusion criteria

• non-anastomotic stricture
• stent implatation technically not feasible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

study group NEPS

Active Comparator group

Description:

implantation of multiple non-expandable plastic stents

Treatment:

Device: Non-expandable plastic stent (plastic endoprosthesis)

group cSEMS

Active Comparator group

Description:

implantation of a self-expandable metal stent (cSEMS)

Treatment:

Device: Covered self-expandable metal stent (cSEMS)