Clinical trial NCT01339078: 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
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Strictures Post Liver Transplantation
Keywords: Biliary strictures
liver transplantation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Comparison of patency of the bile duct between normal and Kaffes stenting.
timeFrame: after 6 months and after 1 year
Secondary outcomes:
measure: safety of the Kaffes stent
timeFrame: during a period of 1 year
measure: Duration of hospitalization
timeFrame: during a period of 1 year
measure: Number of stent changes
timeFrame: during a period of 1 year
measure: Comparison of costs between normal stenting and Kaffes stenting.
timeFrame: during a period of 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hans Van Vlierberghe, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: