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Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

NCT01661686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-10-03

Study results available
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Summary

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Conditions

  • Esophageal Cancer
  • Esophageal Stenosis

Interventions

DEVICE

Partially covered SEMS

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

DEVICE

Fully covered SEMS

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Sponsors & Collaborators

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • Marco J Bruno, M.D., Prof · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-04-30
Completion
2016-10-31

Countries

  • Netherlands

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 NCT01661686 on ClinicalTrials.gov