Covered, Self-expandable Metal Stents (cSEMS) vs. Non-Expandable Plastic Stents (NEPS) in Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorg Albert, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01393067
First received: July 12, 2011
Last updated: June 11, 2015
Last verified: June 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Number of interventions (ERCP) to attain resolution of stenosis [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover
Hannover, Germany, 30625
University Hospital Heidelberg
Heidelberg, Germany, 69120
Italy
University of Milano
Milano, Italy
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Jörg Albert, MD Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
  More Information

Publications:
Responsible Party: Jorg Albert, Johann Wolfgang Goethe University Hospitals., Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01393067     History of Changes
Other Study ID Numbers: 148/10
Study First Received: July 12, 2011
Last Updated: June 11, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
cSEMS
NEPS
ERCP
biliary stricture
biliary stenosis
liver transplantation

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

ClinicalTrials.gov processed this record on July 30, 2015