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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Post OLT biliary stricture resolution after stent removal
Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.
Time frame: Up to 1 year
Sustained improvement after endoscopic treatment
Stricture resolution persistent after 1 year
Time frame: 1 year after biliary stenosis resolution
Occurence and severity of complications related to the endoscopic procedures
Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.
Time frame: Up to 1 month
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