NCT01393067

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Non-expandable plastic stent (plastic endoprosthesis)	plastic stent (plastic endoprosthesis)
DEVICE	Covered self-expandable metal stent (cSEMS)	Removable, covered self-expandable metal stent (cSEMS)

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-07-13
• Last updated: 2016-08-30

Locations

4 sites across 3 countries: Finland, Germany, Italy