Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
- Conditions
- Biliary Anastomotic StenosisBiliary Stricture
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
- jaundice, cholestasis and/or biliary tree dilation on US
- biliary fistulae
- non-anastomotic stricture
- combine anastomotic and non-anastomotic stricture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Related Research Topics
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Trial Locations
- Locations (1)
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, SP, Brazil
Hospital Israelita Albert Einstein🇧🇷Sao Paulo, SP, Brazil