CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
endoscopic balloon dilatation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00487201
NCT00487201N/ACompleted

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

University of Ulm·interventional·Posted Jun 15, 2007·Updated Jun 18, 2007

In Brief

A clinical study evaluating endoscopic balloon dilatation and plastic stent placement for Biliary Obstruction and 2 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2007
Enrollment StartApr 1, 2006
Study CompletionMay 1, 2007
TodayJul 2, 2026
Posted 19.0 years ago

Interventions

endoscopic balloon dilatationprocedure

plastic stent placementprocedure