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

NCT01393067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-08-30

No results posted yet for this study

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).

Conditions

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

Interventions

DEVICE

Non-expandable plastic stent (plastic endoprosthesis)

plastic stent (plastic endoprosthesis)

DEVICE

Covered self-expandable metal stent (cSEMS)

Removable, covered self-expandable metal stent (cSEMS)

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Finland
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393067 on ClinicalTrials.gov