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

NCT00487201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2007-06-18

No results posted yet for this study

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.

Conditions

  • Biliary Obstruction
  • Biliary Stenosis
  • Biliary Stricture

Interventions

PROCEDURE

endoscopic balloon dilatation

PROCEDURE

plastic stent placement

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Hasan Kulaksiz, PD Dr. · Medizinische Universitätsklinik Ulm, Innere Medizin I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2007-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487201 on ClinicalTrials.gov