Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures (COPAC)

September 9, 2019 updated by: Manon Spaander, Foundation for Liver Research

A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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

  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Center
    • Zuid Holland
      • Capelle Aan Den IJssel, Zuid Holland, Netherlands, 2900 AR
        • Ijsselland Hospital
      • Rotterdam, Zuid Holland, Netherlands, 3045 PM
        • Sint Fransiscus gasthuis
      • Rotterdam, Zuid Holland, Netherlands, 3083 AN
        • Ikazia Hospital
      • Zwijndrecht, Zuid Holland, Netherlands, 3331 LZ
        • Albert Schweitzer Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Malignant stricture of the esophagus or cardia
  • No curative treatment options available
  • Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
  • Informed consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Previous treatment with self-expandable metal stent for same condition
  • Evidence of tumor within 2 cm of the upper esophageal sphincter.
  • Presence of an esophago-tracheal or -bronchial fistula or both.
  • Not able to undergo upper endoscopy

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: Insertion of a partially covered SEMS
Device: Partially covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Other Names:
  • WallFlex Partially covered esophageal stent
Active Comparator: Insertion of a Fully covered SEMS
Device: Fully covered SEMS
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Other Names:
  • WallFlex Fully covered esophageal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrent Dysphagia.
Time Frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.
From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Technical Success of SEMS Placement
Time Frame: At stent placement (t=0)
Technical succes was defined as succesful deployment of the stent which bridges the stricture
At stent placement (t=0)
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score
Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months.

Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.

Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months
From stent placement until death or placement of second stent, assessed up to 6 months.
Number of Participants in Whom a Major Complication Has Occured
Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months
A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.
From stent placement until death or placement of second stent, assessed up to 6 months
Median Survival After SEMS Placement
Time Frame: From stent placement until death or placement of second stent
Survival from stent placement until death or placement of second stent
From stent placement until death or placement of second stent

Collaborators and Investigators

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

Sponsor

Foundation for Liver Research

Investigators

  • Study Director: Marco J Bruno, M.D., Prof, Erasmus Medical Center

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 (Actual)

July 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 9, 2012

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPAC

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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