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

Hospital Israelita Albert Einstein

Status and phase: Completed; Phase 3; Phase 2

Conditions: Biliary Stricture; Biliary Anastomotic Stenosis

Treatments: Device: Multiple plastic stents; Device: Self-expandable metalic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01148199

1219-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Multiple plastic stents

Active Comparator group

Description:

Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year

Treatment:

Device: Multiple plastic stents

Self-expandable metalic stent

Experimental group

Description:

Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months

Treatment:

Device: Self-expandable metalic stent