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

December 13, 2022 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital, Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plastic stenting
Patients will be randomized towards plastic stenting.
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.
Experimental: Kaffes stenting
Patients will be randomized towards Kaffes stenting.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of patency of the bile duct between normal and Kaffes stenting.
Time Frame: 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.
after 6 months and after 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of the Kaffes stent
Time Frame: 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)).
during a period of 1 year
Duration of hospitalization
Time Frame: during a period of 1 year
during a period of 1 year
Number of stent changes
Time Frame: 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.
during a period of 1 year
Comparison of costs between normal stenting and Kaffes stenting.
Time Frame: during a period of 1 year
Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.
during a period of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Hans Van Vlierberghe, Ph.D., M.D., University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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