Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
Société Française d'Endoscopie Digestive
180 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria8
- 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
Interventions
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Locations(1)
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NCT05431738