Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
NCT ID: NCT05431738
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-09-01
2025-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STENT WITH ANTI-MIGRATION DEVICE
Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech
Gastroesophageal stent placement
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
STENT WITHOUT ANTI-MIGRATION DEVICE
Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe
Gastroesophageal stent placement
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Interventions
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Gastroesophageal stent placement
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Eligibility Criteria
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Inclusion Criteria
2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
3. Patient ASA 1, ASA 2, ASA 3
4. Absence of participation in another clinical study
5. Signed Informed Consent
6. Patients benefiting from the social security system.
Exclusion Criteria
2. Patients with contraindications relating to the procedures essential for the introduction of a stent
3. Mediastinal radiotherapy or esophageal surgery history
4. Patient under 18 or over 90
5. Patient ASA 4, ASA 5
6. Pregnant Woman
7. Patient unable to give personal consent
8. Absence of signed informed consent
18 Years
91 Years
ALL
No
Sponsors
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Société Française d'Endoscopie Digestive
OTHER
Responsible Party
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KARSENTI
Principal Investigator
Locations
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French Society of Digestive Endoscopy
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANTIMIG
Identifier Type: -
Identifier Source: org_study_id
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