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

Not Applicable

Completed

• Conditions: Biliary Strictures Post Liver Transplantation
• Interventions: Procedure: Plastic stenting; Procedure: Kaffes stenting

• Registration Number: NCT01339078
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plastic stenting	Plastic stenting	Patients will be randomized towards plastic stenting.
Kaffes stenting	Kaffes stenting	Patients will be randomized towards Kaffes stenting.

Primary Outcome Measures

Name	Time	Method
Comparison of patency of the bile duct between normal and Kaffes stenting.	after 6 months and after 1 year	Comparison of patency of the bile duct 6 months after 1 year of stenting. Patency is defined as the presence of normal liver function test (direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT), alkaline phosphatase) and non-dilated bile ducts on Magnetic resonance cholangiopancreatography (MRCP). In the presence of cytomegalovirus (CMV) infection, rejection or other causes of possible disturbed liver function parameters, the MRCP findings rule over the lab tests.

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	during a period of 1 year
safety of the Kaffes stent	during a period of 1 year	The safety of the Kaffes stent, compared to the normal stent will be assessed (e.g. change of stents, blood tests, endoscopic retrograde cholangio-pancreatography (ERCP)).
Number of stent changes	during a period of 1 year	Patients included in the plastic stenting arm will receive change of stents every 3 months for a total duration of 1 year.; Patients included in the Kaffes stent arm will receive change of the stent every 6 months for a total duration of 1 year.; In case the patient develops symptoms of stent occlusion (rise of liver tests, fever, septicimiae), the stent will be changed as soon as possible.
Comparison of costs between normal stenting and Kaffes stenting.	during a period of 1 year	Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.

Trial Locations

Locations (1)

University Hospital, Ghent; 🇧🇪 Ghent, Belgium