Esophageal CancerCOPACNCT01661686
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
A study testing Partially covered SEMS and Fully covered SEMS in people with Esophageal Cancer and Esophageal Stenosis, run by Foundation for Liver Research at 5 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Stenosis
- What is being tested?
- Partially covered SEMS and Fully covered SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesNetherlands
- Study dates
- Jul 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
IJsselland Hospital
Capelle aan den IJssel, South Holland, 2900 AR
Sint Fransiscus Gasthuis
Rotterdam, South Holland, 3045 PM
Ikazia Hospital
Rotterdam, South Holland, 3083 AN
Erasmus Medical Center
Rotterdam, 3015 CE
Albert Schweitzer Hospital
Zwijndrecht, South Holland, 3331 LZ
About this study
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
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
- Being tested
- Partially covered SEMS, Fully covered SEMS
- Keywords
- esophageal cancer, esophageal stenosis, stent, endoscopy
- Medical subject headings
- Esophageal Neoplasms, Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially covered SEMSDevice
Also called WallFlex Partially covered esophageal stent
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
Fully covered SEMSDevice
Also called WallFlex Fully covered esophageal stent
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
| Study group | Role | What they receive |
|---|---|---|
| Insertion of a partially covered SEMS | Active comparator | Not described Receives: Device: Partially covered SEMS |
| Insertion of a Fully covered SEMS | Active comparator | Not described Receives: Device: Fully covered SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Secondary outcomes (4)
Number of Participants With Technical Success of SEMS Placement
Technical succes was defined as succesful deployment of the stent which bridges the stricture
Measured: At stent placement (t=0)
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
Measured: 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
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.
Measured: From stent placement until death or placement of second stent, assessed up to 6 months
Median Survival After SEMS Placement
Survival from stent placement until death or placement of second stent
Measured: From stent placement until death or placement of second stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manon Spaander, Foundation for Liver Research
- Investigators
- Marco J Bruno, M.D., Prof, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661686
- Sponsor's protocol ID
- COPAC
- Acronym
- COPAC
- Status last verified
- Sep 2019
- First submitted
- 1 Aug 2012
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29895072
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01661686
- Acronym / sponsor ID
- COPAC / COPAC
- Conditions
- Esophageal Cancer, Esophageal Stenosis
- Keywords
- esophageal cancer, esophageal stenosis, stent, endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion of a partially covered SEMS | Active comparator | Device: Partially covered SEMS |
| Insertion of a Fully covered SEMS | Active comparator | Device: Fully covered SEMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially covered SEMSAlso: WallFlex Partially covered esophageal stentBoston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available | Device | Insertion of a partially covered SEMS |
| Fully covered SEMSAlso: WallFlex Fully covered esophageal stentBoston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available | Device | Insertion of a Fully covered SEMS |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Technical Success of SEMS Placement
Time frame: 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.
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
Median Survival After SEMS Placement
Time frame: From stent placement until death or placement of second stent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29895072Didden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco J Bruno, M.D., Prof study director
Erasmus Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially covered SEMS and Fully covered SEMS in people with Esophageal Cancer and Esophageal Stenosis, run by Foundation for Liver Research at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.