Stent MigrationANTIMIGNCT05431738
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
A study testing Gastroesophageal stent placement in people with Stent Migration and GastroEsophageal Cancer, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction. Read more about this study
- Who is it for?
- Ages 18 to 91 years
- Conditions the study is for
- Stent Migration, GastroEsophageal Cancer
- What is being tested?
- Gastroesophageal stent placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Sep 2025
- 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 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of both sexes aged 18 or over.
- Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
- Patient ASA 1, ASA 2, ASA 3
- Absence of participation in another clinical study
- Signed Informed Consent
- Patients benefiting from the social security system.
Who cannot join
- Patient referred for stenosis by extrinsic compression by an extra digestive mass
- Patients with contraindications relating to the procedures essential for the introduction of a stent
- Mediastinal radiotherapy or esophageal surgery history
- Patient under 18 or over 90
- Patient ASA 4, ASA 5
- Pregnant Woman
- Patient unable to give personal consent
- Absence of signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
French Society of Digestive Endoscopy
Paris, 75006
David KARSENTI, MD, +33603454293, karsenti.paris@gmail.com
Maira MORENO, PHD, rechercheclinique@sfed.org
About this study
Official title: Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
Read the detailed description
In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.
The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
- Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
- Secondary objective(s):
- Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
- Comparison of the morbidity of these two stents
- Comparison of the effectiveness of these two stents on dysphagia and reflux
- Clinical and technical failure rate of these two stents
This is a prospective, controlled, randomized, multicentre, single-blind study.
- Conditions
- Stent Migration, GastroEsophageal Cancer
- Being tested
- Gastroesophageal stent placement
- Keywords
- Stent Migration, GastroEsophageal Cancer, Esophageal Stenosis, Esophageal cancer, Endoscopy
- Medical subject headings
- Esophageal Stenosis, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastroesophageal stent placementDevice
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
| Study group | Role | What they receive |
|---|---|---|
| STENT WITH ANTI-MIGRATION DEVICE | Active comparator | Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech Receives: Device: Gastroesophageal stent placement |
| STENT WITHOUT ANTI-MIGRATION DEVICE | Active comparator | Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe Receives: Device: Gastroesophageal stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Intragastric migration rate at M1
Stent Intragastric migration rate at M1 confirmed on radiography or CT
Measured: 1 month
Secondary outcomes (12)
Stent Intragastric migration rate at M3
Stent Intragastric migration rate at M3 confirmed on radiography or CT
Measured: 3 months
Stent Intragastric migration rate at M6
Stent Intragastric migration rate at M6 confirmed on radiography or CT
Measured: 6 months
Dysphagia recurrence at M1
Dysphagia evaluation in 5 stages (Atkinson score) at M1 0 - no dysphagia
- - Clinging to the swallowing of solids
- - Semi-liquid feeding possible
- - Liquid feeding possible
- - Aphagia (need for parenteral nutrition)
Measured: 1 month
Dysphagia recurrence at M3
Dysphagia evaluation in 5 stages (Atkinson score) at M3 0 - no dysphagia
- - Clinging to the swallowing of solids
- - Semi-liquid feeding possible
- - Liquid feeding possible
- - Aphagia (need for parenteral nutrition)
Measured: 3 months
Dysphagia recurrence at M6
Dysphagia evaluation in 5 stages (Atkinson score) at M6 0 - no dysphagia
- - Clinging to the swallowing of solids
- - Semi-liquid feeding possible
- - Liquid feeding possible
- - Aphagia (need for parenteral nutrition)
Measured: 6 months
Dysphagia-free survival time
Dysphagia-free survival time at the end of the study
Measured: 3 years
Technical success rate of stent placement
Technical success rate of stent placement under digestive endoscopy defined by good progression of contrast through the stent into the gastric cavity after stent placement
Measured: 1 day
Clinical success rate of stent placement on dysphagia
Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy)
Measured: 3 days
Gastroesophageal reflux disease (GERD) after stent placement
Gastroesophageal reflux disease with the Reflux Disease Questionnaire (RDQ) score. The Reflux Disease Questionnaire a 12-item self-administered questionnaire, was designed to assess the frequency and severity of heartburn, regurgitation, and dyspeptic complaints and to facilitate the diagnosis of GERD. Minimum 12 : better outcome Maximum 72 : worse outcome
Measured: 1 month
Stent placement complication : hemorrhage
Necessity of blood transfusion and/or endoscopic management
Measured: 7 days
Stent placement complication : pain
Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain
Measured: 7 days
Stent placement complication : pneumoperitoneum
Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent MigrationStudies 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
- Model description
- This is a prospective, controlled, randomized, multicentre, single-blind study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431738
- Sponsor's protocol ID
- ANTIMIG
- Acronym
- ANTIMIG
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
- ClinicalTrials.gov ID
- NCT05431738
- Acronym / sponsor ID
- ANTIMIG / ANTIMIG
- Conditions
- Stent Migration, GastroEsophageal Cancer
- Keywords
- Stent Migration, GastroEsophageal Cancer, Esophageal Stenosis, Esophageal cancer, Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jun 2022 (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.
The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
Detailed description
In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.
The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
- Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
- Secondary objective(s):
- Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
- Comparison of the morbidity of these two stents
- Comparison of the effectiveness of these two stents on dysphagia and reflux
- Clinical and technical failure rate of these two stents
This is a prospective, controlled, randomized, multicentre, single-blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, controlled, randomized, multicentre, single-blind study.
| Arm | Type | Receives |
|---|---|---|
| STENT WITH ANTI-MIGRATION DEVICE | Active comparator | Device: Gastroesophageal stent placementPlacement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech |
| STENT WITHOUT ANTI-MIGRATION DEVICE | Active comparator | Device: Gastroesophageal stent placementPlacement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe |
Who may qualify
- Ages
- 18 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of both sexes aged 18 or over.
- Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
- Patient ASA 1, ASA 2, ASA 3
- Absence of participation in another clinical study
- Signed Informed Consent
Key exclusion criteria (8 listed)
- Patient referred for stenosis by extrinsic compression by an extra digestive mass
- Patients with contraindications relating to the procedures essential for the introduction of a stent
- Mediastinal radiotherapy or esophageal surgery history
- Patient under 18 or over 90
- Patient ASA 4, ASA 5
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 |
|---|---|---|
| Gastroesophageal stent placementA gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control | Device | STENT WITH ANTI-MIGRATION DEVICE, STENT WITHOUT ANTI-MIGRATION DEVICE |
Primary outcome
Stent Intragastric migration rate at M1
Time frame: 1 month
Stent Intragastric migration rate at M1 confirmed on radiography or CT
12 secondary outcomes
Stent Intragastric migration rate at M3
Time frame: 3 months
Stent Intragastric migration rate at M6
Time frame: 6 months
Dysphagia recurrence at M1
Time frame: 1 month
Dysphagia recurrence at M3
Time frame: 3 months
Dysphagia recurrence at M6
Time frame: 6 months
Dysphagia-free survival time
Time frame: 3 years
Technical success rate of stent placement
Time frame: 1 day
Clinical success rate of stent placement on dysphagia
Time frame: 3 days
Gastroesophageal reflux disease (GERD) after stent placement
Time frame: 1 month
Stent placement complication : hemorrhage
Time frame: 7 days
Stent placement complication : pain
Time frame: 7 days
Stent placement complication : pneumoperitoneum
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastroesophageal stent placement in people with Stent Migration and GastroEsophageal Cancer, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David KARSENTI, MD (+33603454293, karsenti@club-internet.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Intragastric migration rate at M1 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.