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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393067
First Posted: July 13, 2011
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jorg Albert, Johann Wolfgang Goethe University Hospital
  Purpose
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).

Condition Intervention
Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation Device: Non-expandable plastic stent (plastic endoprosthesis) Device: Covered self-expandable metal stent (cSEMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jorg Albert, Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • Number of interventions (ERCP) to attain resolution of stenosis [ Time Frame: up to one year ]
    Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS


Secondary Outcome Measures:
  • Occurence and severity of complications related to the endoscopic procedures [ Time Frame: up to 2 months after ERCP ]

Enrollment: 60
Study Start Date: March 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: study group NEPS
implantation of multiple non-expandable plastic stents
Device: Non-expandable plastic stent (plastic endoprosthesis)
plastic stent (plastic endoprosthesis)
Other Name: OptiMed, Boston Scientifiv, MTW
Active Comparator: group cSEMS
implantation of a self-expandable metal stent (cSEMS)
Device: Covered self-expandable metal stent (cSEMS)
Removable, covered self-expandable metal stent (cSEMS)
Other Name: Niti-S biliary stent, fully covered

Detailed Description:
This is a multi-center randomised trial.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-OLT stenosis of the bilio-biliary anastomotic

Exclusion Criteria:

  • non-anastomotic stricture
  • stent implatation technically not feasible
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393067


Locations
Finland
University of Helsinki
Helsinki, Finland, 340
Germany
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
Essen, Germany, 45122
Department of Internal Medicine I
Frankfurt, Germany, 60590
Italy
University of Milano
Milano, Italy
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Jörg Albert, MD Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
  More Information