Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00487201
First received: June 13, 2007
Last updated: June 15, 2007
Last verified: May 2007
  Purpose

Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures were dilated subsequently one to three plastic stents with a diameter of eight to ten F were inserted. In general, stents were exchanged in two to three months intervals over one year. In the present prospective controlled study, efficacy and complication rates of balloon dilation have been compared with dilation plus stenting.

Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and non-anastomotic) were enrolled in this prospective study in random order. X patients were treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent placement in six to eight weeks intervals. The primary end point was permanent opening of the biliary obstruction of 12 months. Number of endoscopic interventions and complications of the procedures were monitored.


Condition Intervention
Biliary Obstruction
Biliary Stenosis
Biliary Stricture
Procedure: endoscopic balloon dilatation
Procedure: plastic stent placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Permanent opening of the biliary obstruction. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • number of endoscopic interventions and complications of the procedures [ Time Frame: 12 months ]

Enrollment: 22
Study Start Date: April 2006
Study Completion Date: May 2007
Detailed Description:

Endoscopic treatment was performed by experienced endoscopists who had each performed more than 1000 ERCP procedures. The procedure was performed with the patient under general anesthesia with propofol. A stenosis was considered to be present if the cholangiogram showed strictures with a narrowing of the anastomosis or the proximal donor duct site of the anastomosis and incomplete distal runoff of the contrast agent.

The patients were divided into two groups: 1) balloon dilatation of the stricture, 2) balloon dilatation plus plastic stent placement.

In both groups, endoscopic treatment of the patients comprised sphincterotomy, consecutive dilation of stenosis up to 10 F, removement of occluding material from choledochus duct using a balloon catheter if necessary, and repetitive balloon dilatation of the anastomosis stricture or of the non-anastomotic proximal donor duct stricture to 18 F at the first intervention and to 24 F in the following interventions.

The second group of the patients were additionally treated by large-diameter (10 F) plastic stent placement after balloon dilatation. This procedure was repeated in 6 - 8 weeks intervals in both groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • liver transplanted patients with diagnosis of biliary obstruction based on endoscopic cholangiopancreaticography older than 18 years male and female

Exclusion Criteria:

  • patients with multiple organ transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487201

Locations
Germany
Uniklinikum Heidelberg
Heidelberg, Baden-Württemberg, Germany
Medizinische Universitätsklinik Ulm
Ulm, Baden-Württemberg, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Hasan Kulaksiz, PD Dr. Medizinische Universitätsklinik Ulm, Innere Medizin I
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00487201     History of Changes
Other Study ID Numbers: 120-2006
Study First Received: June 13, 2007
Last Updated: June 15, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
liver transplantation
biliary strictures
ERCP

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

ClinicalTrials.gov processed this record on April 17, 2014