Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Post OLT biliary stricture resolution after stent removal
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multiple plastic stents
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Intervention: Multiple plastic stents (Device)
Self-expandable metalic stent
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
Intervention: Self-expandable metalic stent (Device)
Outcomes
Primary Outcomes
Post OLT biliary stricture resolution after stent removal
Time Frame: 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 Outcomes
- Occurence and severity of complications related to the endoscopic procedures(Up to 1 month)
- Sustained improvement after endoscopic treatment(1 year after biliary stenosis resolution)
Investigators
FERNANDA PRATA MARTINS
Attending phisician
Hospital Israelita Albert Einstein