Clinical trial NCT01393067: cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
Official title: Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation
Keywords: cSEMS
NEPS
ERCP
biliary stricture
biliary stenosis
liver transplantation
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This is a multi-center randomised trial.

Eligibility criteria: Inclusion Criteria:

* post-OLT stenosis of the bilio-biliary anastomotic

Exclusion Criteria:

* non-anastomotic stricture
* stent implatation technically not feasible

Primary outcomes:
measure: Number of interventions (ERCP) to attain resolution of stenosis
timeFrame: up to one year
Secondary outcomes:
measure: Occurence and severity of complications related to the endoscopic procedures
timeFrame: up to 2 months after ERCP
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Essen
country: Germany
facility: Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
city: Frankfurt
country: Germany
facility: Department of Internal Medicine I
city: Milano
country: Italy
facility: University of Milano
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
name: Jörg Albert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.