Actively Recruiting
Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
Led by Société Française d'Endoscopie Digestive · Updated on 2024-07-30
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the rate of stomach migration of two types of esophageal stents used for patients with locally advanced or metastatic malignant narrowing at the gastroesophageal junction. This prospective, controlled, randomized, multicenter, single-blind study aims to compare stents with and without an anti-migration device to understand their effectiveness and safety in this condition. The study involves placing a gastroesophageal stent during digestive endoscopy under general anesthesia, guided by endoscopic and fluoroscopic control. Participants will receive either a stent with an anti-migration device (Ella®, Leufen, Novatech) or a stent without this device (Hanarostent® ECW, Life Partners Europe). This intervention is compared to assess intragastric migration and other clinical effects. Participants will be monitored for stent migration at 1, 3, and 6 months, as well as recurrence of swallowing difficulties and reflux symptoms. The study also tracks technical and clinical success of stent placement, complications like bleeding and pain, and overall dysphagia-free survival up to three years. The total participation time will vary based on individual follow-up and survival.
CONDITIONS
Brief Title
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient of both sexes aged 18 or over
- Dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic
- Patient classified as ASA 1, ASA 2, or ASA 3
- Not currently participating in another clinical study
- Signed informed consent provided
- Covered by the social security system
You will not qualify if you...
- Stenosis caused by external compression from an extra digestive mass
- Contraindications to procedures necessary for stent placement
- History of mediastinal radiotherapy or esophageal surgery
- Age under 18 or over 90 years
- Patient classified as ASA 4 or ASA 5
- Pregnant women
- Unable to give personal consent
- No signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive placement of a gastroesophageal stent with or without an anti-migration device during digestive endoscopy under general anesthesia.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for complications and effectiveness of the stent including migration, dysphagia, and reflux.
Visits at 1 day, 3 days, 7 days, 1 month, 3 months, and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
French Society of Digestive Endoscopy
Paris, France, 75006
Actively Recruiting
Research Team
D
David KARSENTI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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