Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis

Phase 2

Completed

• Conditions: Biliary Anastomotic Stenosis; Biliary Stricture
• Interventions: Device: Multiple plastic stents; Device: Self-expandable metalic stent

• Registration Number: NCT01148199
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients.

Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.

Detailed Description

Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups.

Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
• jaundice, cholestasis and/or biliary tree dilation on US

Exclusion Criteria

• biliary fistulae
• non-anastomotic stricture
• combine anastomotic and non-anastomotic stricture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple plastic stents	Multiple plastic stents	Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Self-expandable metalic stent	Self-expandable metalic stent	Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months

Primary Outcome Measures

Name	Time	Method
Post OLT biliary stricture resolution after stent removal	Up to 1 year	Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.

Secondary Outcome Measures

Name	Time	Method
Occurence and severity of complications related to the endoscopic procedures	Up to 1 month	Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.
Sustained improvement after endoscopic treatment	1 year after biliary stenosis resolution	Stricture resolution persistent after 1 year

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, SP, Brazil