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

August 27, 2016 updated by: Jorg Albert, Johann Wolfgang Goethe University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center randomised trial.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 340
        • University of Helsinki
  • Germany
      • Essen, Germany, 45122
        • Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
      • Frankfurt, Germany, 60590
        • Department of Internal Medicine I
  • Italy
      • Milano, Italy
        • University of Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post-OLT stenosis of the bilio-biliary anastomotic

Exclusion Criteria:

  • non-anastomotic stricture
  • stent implatation technically not feasible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Niti-S biliary stent, fully covered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurence and severity of complications related to the endoscopic procedures
Time Frame: up to 2 months after ERCP
up to 2 months after ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Jörg Albert, MD, Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 27, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 148/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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