A Phase 2/3 interventional study of Self-expandable metalic stent and Multiple plastic stents in Biliary Anastomotic Stenosis and Biliary Stricture, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by Hospital Israelita Albert Einstein · Phase 2/3, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Device: Multiple plastic stents
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
Device: Self-expandable metalic stent
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Also known as: Wallflex, Boston Scientific
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Also known as: Boston Scientific, Wilson Cook, Olympus
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
Plan to share: Undecided
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Hospital Israelita Albert Einstein