Oesophageal CancerEATERSNCT04415463
Esophageal Multisegmented FCSEMS for Malignant Strictures
A study testing Multisegmented fully covered self-expandable metal stent in people with Oesophageal Cancer and Esophageal Stent Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia. Study design: Prospective observational nonrandomized clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Esophageal Stent Stenosis
- What is being tested?
- Multisegmented fully covered self-expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Mar 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- Requiring treatment for dysphagia (Ogilvie score of 2-41);
- Life expectancy of less than 12 months.
Who cannot join
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Esophageal fistula;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Inappropriate cultural level and understanding of the study;
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- Coagulopathy;
- Patients with eosinophilic esophagitis or an esophageal motility disorder;
- Nickel titanium (Nitinol) allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.
Study design: Prospective observational nonrandomized clinical study.
Read more
Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.
Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.
Primary end points:
- Safety: complications and adverse events during follow-up with special attention to stent migration rates;
- Efficacy: technical success of stent placement.
Secondary end points:
- Recurrent dysphagia including its cause;
- Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
- Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
- Pain related to esophageal stent.
- Conditions
- Oesophageal Cancer, Esophageal Stent Stenosis
- Being tested
- Multisegmented fully covered self-expandable metal stent
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisegmented fully covered self-expandable metal stentDevice
Esophageal FC-SEMS
| Study group | Role | What they receive |
|---|---|---|
| FC-SEMS | Experimental | Placement of multisegmented fully covered self-expandable metal stent Receives: Device: Multisegmented fully covered self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events during follow-up
Measured: 6 months
Technical success of stent placement
Technical success of stent placement
Measured: 1 day
Secondary outcomes (4)
Recurrent dysphagia
Ogilvie dysphagia score
Measured: 6 months
Functional outcome
WHO performance score
Measured: 6 months
Tissue ingrowth or overgrowth
Measured: 6 months
Pain related to esophageal stent
Measured using the Visual Analogue Scale (VAS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start3 Mar 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415463
- Sponsor's protocol ID
- NL73180.091.20
- Acronym
- EATERS
- Status last verified
- Jan 2023
- First submitted
- 25 May 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koggel LM, Reijm AN, Lantinga MA, de Jong DJ, Rodrigues-Pinto E, Spaander MCW, Siersema PD. Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study. Gastrointest Endosc. 2024 Jun;99(6):1027-1031.e6. doi: 10.1016/j.gie.2024.01.045. Epub 2024 Feb 3.
PubMed 38316224
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)
- ClinicalTrials.gov ID
- NCT04415463
- Acronym / sponsor ID
- EATERS / NL73180.091.20
- Conditions
- Oesophageal Cancer, Esophageal Stent Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.
Study design: Prospective observational nonrandomized clinical study.
Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.
Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.
Primary end points:
- Safety: complications and adverse events during follow-up with special attention to stent migration rates;
- Efficacy: technical success of stent placement.
Secondary end points:
- Recurrent dysphagia including its cause;
- Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
- Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
- Pain related to esophageal stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FC-SEMS | Experimental | Device: Multisegmented fully covered self-expandable metal stentPlacement of multisegmented fully covered self-expandable metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- Requiring treatment for dysphagia (Ogilvie score of 2-41);
- Life expectancy of less than 12 months.
Key exclusion criteria (9 listed)
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Esophageal fistula;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
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 |
|---|---|---|
| Multisegmented fully covered self-expandable metal stentEsophageal FC-SEMS | Device | FC-SEMS |
Primary outcome
Adverse events
Time frame: 6 months
Adverse events during follow-up
Technical success of stent placement
Time frame: 1 day
Technical success of stent placement
4 secondary outcomes
Recurrent dysphagia
Time frame: 6 months
Functional outcome
Time frame: 6 months
Tissue ingrowth or overgrowth
Time frame: 6 months
Pain related to esophageal stent
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38316224Koggel LM, Reijm AN, Lantinga MA, de Jong DJ, Rodrigues-Pinto E, Spaander MCW, Siersema PD. Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study. Gastrointest Endosc. 2024 Jun;99(6):1027-1031.e6. doi: 10.1016/j.gie.2024.01.045. Epub 2024 Feb 3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisegmented fully covered self-expandable metal stent in people with Oesophageal Cancer and Esophageal Stent Stenosis, run by Radboud University Medical Center at 1 site 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
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?
Adverse events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04415463, 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 12 Jan 2023.