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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05431738
Study type Interventional
Source Société Française d'Endoscopie Digestive
Contact David KARSENTI, MD
Phone +33603454293
Email karsenti@club-internet.fr
Status Not yet recruiting
Phase N/A
Start date September 1, 2022
Completion date September 1, 2025

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