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

Primary Purpose

Biliary Strictures Post Liver Transplantation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Plastic stenting
Kaffes stenting
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Strictures Post Liver Transplantation focused on measuring Biliary strictures, liver transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital, Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Plastic stenting

Kaffes stenting

Arm Description

Patients will be randomized towards plastic stenting.

Patients will be randomized towards Kaffes stenting.

Outcomes

Primary Outcome Measures

Comparison of patency of the bile duct between normal and Kaffes stenting.
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

safety of the Kaffes stent
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)).
Duration of hospitalization
Number of stent changes
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.
Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.

Full Information

First Posted
April 18, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01339078
Brief Title
Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
Official Title
Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Strictures Post Liver Transplantation
Keywords
Biliary strictures, liver transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plastic stenting
Arm Type
Active Comparator
Arm Description
Patients will be randomized towards plastic stenting.
Arm Title
Kaffes stenting
Arm Type
Experimental
Arm Description
Patients will be randomized towards Kaffes stenting.
Intervention Type
Procedure
Intervention Name(s)
Plastic stenting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Kaffes stenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of patency of the bile duct between normal and Kaffes stenting.
Description
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.
Time Frame
after 6 months and after 1 year
Secondary Outcome Measure Information:
Title
safety of the Kaffes stent
Description
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)).
Time Frame
during a period of 1 year
Title
Duration of hospitalization
Time Frame
during a period of 1 year
Title
Number of stent changes
Description
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.
Time Frame
during a period of 1 year
Title
Comparison of costs between normal stenting and Kaffes stenting.
Description
Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.
Time Frame
during a period of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Van Vlierberghe, Ph.D., M.D.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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