NCT01339078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

4.3 years

First QC Date

April 18, 2011

Last Update Submit

December 13, 2022

Conditions

Biliary Strictures Post Liver Transplantation

Keywords

Biliary stricturesliver transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 6 months and after 1 year

Secondary Outcomes (4)

  • safety of the Kaffes stent

    during a period of 1 year

  • Duration of hospitalization

    during a period of 1 year

  • Number of stent changes

    during a period of 1 year

  • Comparison of costs between normal stenting and Kaffes stenting.

    during a period of 1 year

Study Arms (2)

Plastic stenting

ACTIVE COMPARATOR

Patients will be randomized towards plastic stenting.

Procedure: Plastic stenting

Kaffes stenting

EXPERIMENTAL

Patients will be randomized towards Kaffes stenting.

Procedure: Kaffes stenting

Interventions

Plastic stentingPROCEDURE

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.

Plastic stenting
Kaffes stentingPROCEDURE

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.

Kaffes stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent

Ghent, Belgium

Location

Related Links

Study Officials

  • Hans Van Vlierberghe, Ph.D., M.D.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 20, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

BE(1)