Status:

COMPLETED

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

Lead Sponsor:

Hospital Israelita Albert Einstein

Conditions:

Biliary Anastomotic Stenosis

Biliary Stricture

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

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...

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...

Eligibility Criteria

Inclusion

  • post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
  • jaundice, cholestasis and/or biliary tree dilation on US

Exclusion

  • biliary fistulae
  • non-anastomotic stricture
  • combine anastomotic and non-anastomotic stricture

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2016

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT01148199

Start Date

August 1 2009

End Date

February 1 2016

Last Update

June 26 2018

Active Locations (1)

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1

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil, 05652900