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

Primary Purpose

Esophageal Cancer, Esophageal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Partially covered SEMS
Fully covered SEMS
Sponsored by
Foundation for Liver Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, esophageal stenosis, stent, endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IJsselland Hospital
  • Sint Fransiscus Gasthuis
  • Ikazia Hospital
  • Albert Schweitzer Hospital
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Insertion of a partially covered SEMS

Insertion of a Fully covered SEMS

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Recurrent Dysphagia.
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.

Secondary Outcome Measures

Number of Participants With Technical Success of SEMS Placement
Technical succes was defined as succesful deployment of the stent which bridges the stricture
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score
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
Number of Participants in Whom a Major Complication Has Occured
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.
Median Survival After SEMS Placement
Survival from stent placement until death or placement of second stent

Full Information

First Posted
August 1, 2012
Last Updated
September 9, 2019
Sponsor
Foundation for Liver Research
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1. Study Identification

Unique Protocol Identification Number
NCT01661686
Brief Title
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
Acronym
COPAC
Official Title
A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation for Liver Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophageal Stenosis
Keywords
esophageal cancer, esophageal stenosis, stent, endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insertion of a partially covered SEMS
Arm Type
Active Comparator
Arm Title
Insertion of a Fully covered SEMS
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Partially covered SEMS
Other Intervention Name(s)
WallFlex Partially covered esophageal stent
Intervention Description
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Intervention Type
Device
Intervention Name(s)
Fully covered SEMS
Other Intervention Name(s)
WallFlex Fully covered esophageal stent
Intervention Description
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Primary Outcome Measure Information:
Title
Number of Participants With Recurrent Dysphagia.
Description
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.
Time Frame
From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Secondary Outcome Measure Information:
Title
Number of Participants With Technical Success of SEMS Placement
Description
Technical succes was defined as succesful deployment of the stent which bridges the stricture
Time Frame
At stent placement (t=0)
Title
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score
Description
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
Time Frame
From stent placement until death or placement of second stent, assessed up to 6 months.
Title
Number of Participants in Whom a Major Complication Has Occured
Description
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.
Time Frame
From stent placement until death or placement of second stent, assessed up to 6 months
Title
Median Survival After SEMS Placement
Description
Survival from stent placement until death or placement of second stent
Time Frame
From stent placement until death or placement of second stent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco J Bruno, M.D., Prof
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
IJsselland Hospital
City
Capelle Aan Den IJssel
State/Province
Zuid Holland
ZIP/Postal Code
2900 AR
Country
Netherlands
Facility Name
Sint Fransiscus Gasthuis
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Ikazia Hospital
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Albert Schweitzer Hospital
City
Zwijndrecht
State/Province
Zuid Holland
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29895072
Citation
Didden P, Reijm AN, Erler NS, Wolters LMM, Tang TJ, Ter Borg PCJ, Leeuwenburgh I, Bruno MJ, Spaander MCW. Fully vs. partially covered selfexpandable metal stent for palliation of malignant esophageal strictures: a randomized trial (the COPAC study). Endoscopy. 2018 Oct;50(10):961-971. doi: 10.1055/a-0620-8135. Epub 2018 Jun 12.
Results Reference
derived

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Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

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