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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Foundation for Liver Research
Sponsor:
Information provided by (Responsible Party):
Manon Spaander, Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01661686
First received: August 1, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Esophageal Cancer
Esophageal Stenosis
Device: Partially covered SEMS
Device: Fully covered SEMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • Recurrent dysphagia. [ Time Frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]
    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:
  • Technical success of SEMS placement [ Time Frame: At stent placement (t=0) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    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

  • Major and minor complication rate [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]
    This will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and the EOS18, at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months.

  • Survival [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: WallFlex Fully covered esophageal stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661686

Contacts
Contact: Manon CW Spaander, M.D., PhD +31107035643 v.spaander@erasmusmc.nl
Contact: Paul Didden, M.D. +31107040704 ext *3609 p.didden@erasmusmc.nl

Locations
Netherlands
IJsselland Hospital Recruiting
Capelle a/d IJssel, Zuid Holland, Netherlands, 2900 AR
Contact: Tang       tjtang@ysl.nl   
Principal Investigator: Thjon Tang, MD, PhD         
Ikazia Hospital Recruiting
Rotterdam, Zuid Holland, Netherlands, 3083 AN
Contact: Ter Borg       pcj.ter.borg@ikazia.nl   
Principal Investigator: Pieter CJ ter Borg, MD, PhD         
Sint Fransiscus Gasthuis Recruiting
Rotterdam, Zuid Holland, Netherlands, 3045 PM
Contact: Leeuwenburg       i.leeuwenburgh@sfg.nl   
Principal Investigator: I Leeuwenburg, MD, PhD         
Albert Schweitzer Hospital Recruiting
Zwijndrecht, Zuid Holland, Netherlands, 3331 LZ
Contact: Wolters       L.M.M.Wolters@asz.nl   
Principal Investigator: Leonieke MM Wolters, MD, PhD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Manon CW Spaander       v.spaander@erasmusmc.nl   
Contact: Paul Didden       p.didden@erasmusmc.nl   
Principal Investigator: Manon CW Spaander, M.D., PhD         
Sponsors and Collaborators
Foundation for Liver Research
Investigators
Study Director: Marco J Bruno, M.D., Prof Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Manon Spaander, M.D., PhD, Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT01661686     History of Changes
Other Study ID Numbers: COPAC
Study First Received: August 1, 2012
Last Updated: July 28, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Foundation for Liver Research:
esophageal cancer
esophageal stenosis
stent
endoscopy

Additional relevant MeSH terms:
Esophageal Neoplasms
Esophageal Stenosis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014