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Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).
This is a multi-center randomised trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group NEPS | Active Comparator | implantation of multiple non-expandable plastic stents |
|
| group cSEMS | Active Comparator | implantation of a self-expandable metal stent (cSEMS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-expandable plastic stent (plastic endoprosthesis) | Device | plastic stent (plastic endoprosthesis) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of interventions (ERCP) to attain resolution of stenosis | Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence and severity of complications related to the endoscopic procedures | up to 2 months after ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Albert, MD | Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki | Helsinki | 340 | Finland | |||
| Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18294506 | Background | 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. | |
| 19693751 | Background |
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| Covered self-expandable metal stent (cSEMS) | Device | Removable, covered self-expandable metal stent (cSEMS) |
|
|
| Essen |
| 45122 |
| Germany |
| Department of Internal Medicine I | Frankfurt | 60590 | Germany |
| University of Milano | Milan | Italy |
| 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. |
| 21618151 | Background | 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. |
| 28302527 | Derived | 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. |