RecruitingNot ApplicableNCT05431738

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


Sponsor

Société Française d'Endoscopie Digestive

Enrollment

180 participants

Start Date

Sep 1, 2022

Study Type

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

Min Age: 18 YearsMax Age: 91 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of esophageal stent — a small tube placed inside the food pipe to keep it open — that is designed to stay in place better and reduce complications like the stent shifting or moving after insertion. It is for people who have difficulty swallowing due to a tumor at the junction of the food pipe and stomach. **You may be eligible if:** - You are 18 or older (but under 90) - You have difficulty swallowing caused by a tumor at the junction of the esophagus and stomach, either locally advanced or metastatic - You are in a stable enough health condition for the procedure - You are covered by social security **You may NOT be eligible if:** - Your swallowing problem is caused by pressure from an external tumor (not a tumor within the esophagus itself) - You have had prior radiation to the chest or previous esophageal surgery - You are pregnant - You are under 18 or over 90 - You are in the most severe health categories (ASA 4 or 5) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGastroesophageal stent placement

A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control


Locations(1)

French Society of Digestive Endoscopy

Paris, France

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NCT05431738


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