Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement
Primary Purpose
Biliary Obstruction, Biliary Stenosis, Biliary Stricture
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
endoscopic balloon dilatation
plastic stent placement
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Obstruction focused on measuring liver transplantation, biliary strictures, ERCP
Eligibility 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
Sites / Locations
- Uniklinikum Heidelberg
- Medizinische Universitätsklinik Ulm
Outcomes
Primary Outcome Measures
Permanent opening of the biliary obstruction.
Secondary Outcome Measures
number of endoscopic interventions and complications of the procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487201
Brief Title
Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Obstruction, Biliary Stenosis, Biliary Stricture
Keywords
liver transplantation, biliary strictures, ERCP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
endoscopic balloon dilatation
Intervention Type
Procedure
Intervention Name(s)
plastic stent placement
Primary Outcome Measure Information:
Title
Permanent opening of the biliary obstruction.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
number of endoscopic interventions and complications of the procedures
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Kulaksiz, PD Dr.
Organizational Affiliation
Medizinische Universitätsklinik Ulm, Innere Medizin I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Medizinische Universitätsklinik Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10094945
Citation
Graziadei IW, Wiesner RH, Batts KP, Marotta PJ, LaRusso NF, Porayko MK, Hay JE, Gores GJ, Charlton MR, Ludwig J, Poterucha JJ, Steers JL, Krom RA. Recurrence of primary sclerosing cholangitis following liver transplantation. Hepatology. 1999 Apr;29(4):1050-6. doi: 10.1002/hep.510290427.
Results Reference
background
PubMed Identifier
8911805
Citation
Sossenheimer M, Slivka A, Carr-Locke D. Management of extrahepatic biliary disease after orthotopic liver transplantation: review of the literature and results of a multicenter survey. Endoscopy. 1996 Sep;28(7):565-71. doi: 10.1055/s-2007-1005556. No abstract available.
Results Reference
background
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Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement
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