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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Biliary Strictures Post Liver Transplantation

Treatments: Procedure: Plastic stenting; Procedure: Kaffes stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01339078

2011/255

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture

• diagnosis established by :

  • elevated liver tests
  • a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
  • no acute or chronic rejection
  • no Cytomegalovirus (CMV) infection
  • no other possible causes of elevated liver tests
  • confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.

Exclusion criteria

• non-anastomotic strictures
• absence of informed consent
• Roux-en-Y construction
• Living related liver transplantation patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Plastic stenting

Active Comparator group

Description:

Patients will be randomized towards plastic stenting.

Treatment:

Procedure: Plastic stenting

Kaffes stenting

Experimental group

Description:

Patients will be randomized towards Kaffes stenting.

Treatment:

Procedure: Kaffes stenting