Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement
1 other identifier
interventional
22
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedJune 18, 2007
May 1, 2007
June 13, 2007
June 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Permanent opening of the biliary obstruction.
12 months
Secondary Outcomes (1)
number of endoscopic interventions and complications of the procedures
12 months
Interventions
Eligibility Criteria
You may qualify if:
- liver transplanted patients with diagnosis of biliary obstruction based on endoscopic cholangiopancreaticography older than 18 years male and female
You may not qualify if:
- patients with multiple organ transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Uniklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Medizinische Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Related Publications (2)
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.
PMID: 10094945BACKGROUNDSossenheimer 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.
PMID: 8911805BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Hasan Kulaksiz, PD Dr.
Medizinische Universitätsklinik Ulm, Innere Medizin I
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 15, 2007
Study Start
April 1, 2006
Study Completion
May 1, 2007
Last Updated
June 18, 2007
Record last verified: 2007-05