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| Sponsored by: |
University of Ulm |
|---|---|
| Information provided by: | University of Ulm |
| ClinicalTrials.gov Identifier: | NCT00487201 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Biliary Obstruction Biliary Stenosis Biliary Stricture |
Procedure: endoscopic balloon dilatation Procedure: plastic stent placement |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment: | 22 |
| Study Start Date: | April 2006 |
| Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany, Baden-Württemberg | |
| Medizinische Universitätsklinik Ulm | |
| Ulm, Baden-Württemberg, Germany, 89081 | |
| Uniklinikum Heidelberg | |
| Heidelberg, Baden-Württemberg, Germany | |
| Principal Investigator: | Hasan Kulaksiz, PD Dr. | Medizinische Universitätsklinik Ulm, Innere Medizin I |
More Information
| Study ID Numbers: | 120-2006 |
| Study First Received: | June 13, 2007 |
| Last Updated: | June 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00487201 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
liver transplantation biliary strictures ERCP |
|
Pathological Conditions, Anatomical Digestive System Diseases Dilatation, Pathologic Bile Duct Diseases |
Cholestasis Biliary Tract Diseases Constriction, Pathologic |
