NCT05431738

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 91 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stent Migration
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DEVICE	Gastroesophageal stent placement	A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-06-24
• Last updated: 2024-07-30

Locations

1 site across 1 country: France