cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
NCT ID: NCT01393067
Last Updated: 2016-08-30
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
NA
60 participants
INTERVENTIONAL
2011-03-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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study group NEPS
implantation of multiple non-expandable plastic stents
Non-expandable plastic stent (plastic endoprosthesis)
plastic stent (plastic endoprosthesis)
group cSEMS
implantation of a self-expandable metal stent (cSEMS)
Covered self-expandable metal stent (cSEMS)
Removable, covered self-expandable metal stent (cSEMS)
Interventions
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Non-expandable plastic stent (plastic endoprosthesis)
plastic stent (plastic endoprosthesis)
Covered self-expandable metal stent (cSEMS)
Removable, covered self-expandable metal stent (cSEMS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* stent implatation technically not feasible
18 Years
90 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Jorg Albert
Johann Wolfgang Goethe University Hospitals.
Principal Investigators
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Jörg Albert, MD
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
Locations
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University of Helsinki
Helsinki, , Finland
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
Essen, , Germany
Department of Internal Medicine I
Frankfurt, , Germany
University of Milano
Milan, , Italy
Countries
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References
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Phillips MS, Bonatti H, Sauer BG, Smith L, Javaid M, Kahaleh M, Schmitt T. Elevated stricture rate following the use of fully covered self-expandable metal biliary stents for biliary leaks following liver transplantation. Endoscopy. 2011 Jun;43(6):512-7. doi: 10.1055/s-0030-1256389. Epub 2011 May 26.
Tal AO, Finkelmeier F, Filmann N, Kylanpaa L, Udd M, Parzanese I, Cantu P, Dechene A, Penndorf V, Schnitzbauer A, Friedrich-Rust M, Zeuzem S, Albert JG. Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial. Gastrointest Endosc. 2017 Dec;86(6):1038-1045. doi: 10.1016/j.gie.2017.03.009. Epub 2017 Mar 14.
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.
Wang AY, Ellen K, Berg CL, Schmitt TM, Kahaleh M. Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data - a case series. Endoscopy. 2009 Sep;41(9):781-6. doi: 10.1055/s-0029-1215050. Epub 2009 Aug 19.
Other Identifiers
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148/10
Identifier Type: -
Identifier Source: org_study_id
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