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OpenTrials
Completed

NCT Number: NCT01148199

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

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.

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Key information

Conditions

Biliary Anastomotic Stenosis Biliary Stricture

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-expandable metalic stent

Device

Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Other names: Wallflex, Boston Scientific

Multiple plastic stents

Device

Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Other names: Boston Scientific, Wilson Cook, Olympus

Primary outcomes

  1. Post OLT biliary stricture resolution after stent removal

    Time frame: Up to 1 year

    Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.

Secondary outcomes

  1. Sustained improvement after endoscopic treatment

    Time frame: 1 year after biliary stenosis resolution

    Stricture resolution persistent after 1 year

  2. Occurence and severity of complications related to the endoscopic procedures

    Time frame: Up to 1 month

    Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Jun 22, 2010
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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