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

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ClinicalTrials.gov Identifier: NCT01393067
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jorg Albert, Johann Wolfgang Goethe University Hospital

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).

Condition or disease Intervention/treatment Phase
Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation Device: Non-expandable plastic stent (plastic endoprosthesis) Device: Covered self-expandable metal stent (cSEMS) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Occurence and severity of complications related to the endoscopic procedures [ Time Frame: up to 2 months after ERCP ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jorg Albert, Johann Wolfgang Goethe University Hospitals., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01393067     History of Changes
Other Study ID Numbers: 148/10
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Jorg Albert, Johann Wolfgang Goethe University Hospital:
cSEMS
NEPS
ERCP
biliary stricture
biliary stenosis
liver transplantation

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical