Spots Global Cancer Trial Database for Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

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Trial Identification

Brief Title: Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

Official Title: Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study

Study ID: NCT05431738

Conditions

Stent Migration

GastroEsophageal Cancer

Interventions

Gastroesophageal stent placement

Study Description

Brief 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.

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.