cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393067
• Other study ID #: 148/10
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: August 27, 2016
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Description:

This is a multi-center randomised trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• post-OLT stenosis of the bilio-biliary anastomotic

Exclusion Criteria:

• non-anastomotic stricture

• stent implatation technically not feasible

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Intervention

Device:
• Non-expandable plastic stent (plastic endoprosthesis)
plastic stent (plastic endoprosthesis)
• Covered self-expandable metal stent (cSEMS)
Removable, covered self-expandable metal stent (cSEMS)

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki
Germany	Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen	Essen
Germany	Department of Internal Medicine I	Frankfurt
Italy	University of Milano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Countries where clinical trial is conducted

Finland,  Germany,  Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Occurence and severity of complications related to the endoscopic procedures		up to 2 months after ERCP	Yes