NCT01339078

Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation

Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion. The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months). No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.

Conditions

• Biliary Strictures Post Liver Transplantation

Interventions

Type	Name	Description
PROCEDURE	Plastic stenting	The patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year.
PROCEDURE	Kaffes stenting	The patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-04-20
• Last updated: 2022-12-15

Locations

1 site across 1 country: Belgium