Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
NCT ID: NCT01148199
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2009-08-31
2016-02-29
Brief Summary
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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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Detailed Description
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Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multiple plastic stents
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Multiple plastic stents
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Self-expandable metalic stent
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
Self-expandable metalic stent
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Interventions
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Self-expandable metalic stent
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Multiple plastic stents
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* jaundice, cholestasis and/or biliary tree dilation on US
Exclusion Criteria
* non-anastomotic stricture
* combine anastomotic and non-anastomotic stricture
18 Years
75 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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FERNANDA PRATA MARTINS
Attending phisician
Principal Investigators
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FERNANDA P MARTINS, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein
ANGELO P FERRARI, MD
Role: STUDY_CHAIR
Hospital Israelita Albert Einstein
Locations
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Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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References
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Mahajan A, Ho H, Sauer B, Phillips MS, Shami VM, Ellen K, Rehan M, Schmitt TM, Kahaleh M. Temporary placement of fully covered self-expandable metal stents in benign biliary strictures: midterm evaluation (with video). Gastrointest Endosc. 2009 Aug;70(2):303-9. doi: 10.1016/j.gie.2008.11.029. Epub 2009 Jun 11.
Kahaleh M, Behm B, Clarke BW, Brock A, Shami VM, De La Rue SA, Sundaram V, Tokar J, Adams RB, Yeaton P. Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video). Gastrointest Endosc. 2008 Mar;67(3):446-54. doi: 10.1016/j.gie.2007.06.057.
Traina M, Tarantino I, Barresi L, Volpes R, Gruttadauria S, Petridis I, Gridelli B. Efficacy and safety of fully covered self-expandable metallic stents in biliary complications after liver transplantation: a preliminary study. Liver Transpl. 2009 Nov;15(11):1493-8. doi: 10.1002/lt.21886.
Other Identifiers
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1219-10
Identifier Type: -
Identifier Source: org_study_id
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