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

NCT01148199 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-06-26

No results posted yet for this study

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 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.

Conditions

  • Biliary Anastomotic Stenosis
  • Biliary Stricture

Interventions

DEVICE

Self-expandable metalic stent

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

DEVICE

Multiple plastic stents

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

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • FERNANDA P MARTINS, MD · Hospital Israelita Albert Einstein

  • ANGELO P FERRARI, MD · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2015-02-28
Completion
2016-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148199 on ClinicalTrials.gov