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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01339078
First received: April 18, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Biliary Strictures Post Liver Transplantation.
Procedure: Plastic stenting
Procedure: Kaffes stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Comparison of patency of the bile duct between normal and Kaffes stenting. [ Time Frame: after 6 months and after 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: during a period of 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during a period of 1 year ] [ Designated as safety issue: No ]
  • Number of stent changes [ Time Frame: during a period of 1 year ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: during a period of 1 year ] [ Designated as safety issue: No ]
    Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339078

Contacts
Contact: Hans Van Vlierberghe, Ph.D. , M.D. Hans.Vanvlierberghe@ugent.be

Locations
Belgium
University Hospital, Ghent Recruiting
Ghent, Belgium
Contact: Hans Van Vlierberghe, Ph.D. , M.D.       Hans.Vanvlierberghe@ugent.be   
Principal Investigator: Hans Van Vlierberghe, Ph.D. , M.D.         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hans Van Vlierberghe, Ph.D. , M.D. University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01339078     History of Changes
Other Study ID Numbers: 2011/255
Study First Received: April 18, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Biliary strictures
liver transplantation

Additional relevant MeSH terms:
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 15, 2014