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

What this Trial Is About

Researchers are evaluating the rate of stomach migration of two types of esophageal stents used for patients with locally advanced or metastatic malignant narrowing at the gastroesophageal junction. This prospective, controlled, randomized, multicenter, single-blind study aims to compare stents with and without an anti-migration device to understand their effectiveness and safety in this condition. The study involves placing a gastroesophageal stent during digestive endoscopy under general anesthesia, guided by endoscopic and fluoroscopic control. Participants will receive either a stent with an anti-migration device Ella, Leufen, Novatech or a stent without this device Hanarostent ECW, Life Partners Europe. This intervention is compared to assess intragastric migration and other clinical effects. Participants will be monitored for stent migration at 1, 3, and 6 months, as well as recurrence of swallowing difficulties and reflux symptoms. The study also tracks technical and clinical success of stent placement, complications like bleeding and pain, and overall dysphagia-free survival up to three years. The total participation time will vary based on individual follow-up and survival.

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