Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00487201
Study type	Interventional
Source	University of Ulm
Contact
Status	Completed
Phase	N/A
Start date	April 2006
Completion date	May 2007

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms