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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.

Conditions
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Biliary Anastomotic Stenosis, Biliary Stricture

Intervention / Treatment
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* Device: Self-expandable metalic stent
* Device: Multiple plastic stents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multiple plastic stents<br>Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year | Device: Multiple plastic stents<br>* Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.<br>* Other names: Olympus;|
| Experimental: Self-expandable metalic stent<br>Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months | Device: Self-expandable metalic stent<br>* Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.<br>* Other names: Wallflex, Boston Scientific;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained improvement after endoscopic treatment | Stricture resolution persistent after 1 year | 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. | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary anastomotic stricture, orthotopic liver transplantation, ERCP