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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stent Migration, GastroEsophageal Cancer

Intervention / Treatment
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* Device: Gastroesophageal stent placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of both sexes aged 18 or over. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic. Patient ASA 1, ASA 2, ASA 3 Absence of participation in another clinical study Signed Informed Consent Patients benefiting from the social security system. Exclusion Criteria: Patient referred for stenosis by extrinsic compression by an extra digestive mass Patients with contraindications relating to the procedures essential for the introduction of a stent Mediastinal radiotherapy or esophageal surgery history Patient under 18 or over 90 Patient ASA 4, ASA 5 Pregnant Woman Patient unable to give personal consent Absence of signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 91 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, controlled, randomized, multicentre, single-blind study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STENT WITH ANTI-MIGRATION DEVICE<br>Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech | Device: Gastroesophageal stent placement<br>* A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control<br>|
| Active Comparator: STENT WITHOUT ANTI-MIGRATION DEVICE<br>Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe | Device: Gastroesophageal stent placement<br>* A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Intragastric migration rate at M1 | Stent Intragastric migration rate at M1 confirmed on radiography or CT | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Intragastric migration rate at M3 | Stent Intragastric migration rate at M3 confirmed on radiography or CT | 3 months | 
| Stent Intragastric migration rate at M6 | Stent Intragastric migration rate at M6 confirmed on radiography or CT | 6 months | 
| Dysphagia recurrence at M1 | Dysphagia evaluation in 5 stages (Atkinson score) at M1 0 - no dysphagia - Clinging to the swallowing of solids - Semi-liquid feeding possible - Liquid feeding possible - Aphagia (need for parenteral nutrition) | 1 month | 
| Dysphagia recurrence at M3 | Dysphagia evaluation in 5 stages (Atkinson score) at M3 0 - no dysphagia - Clinging to the swallowing of solids - Semi-liquid feeding possible - Liquid feeding possible - Aphagia (need for parenteral nutrition) | 3 months | 
| Dysphagia recurrence at M6 | Dysphagia evaluation in 5 stages (Atkinson score) at M6 0 - no dysphagia - Clinging to the swallowing of solids - Semi-liquid feeding possible - Liquid feeding possible - Aphagia (need for parenteral nutrition) | 6 months | 
| Dysphagia-free survival time | Dysphagia-free survival time at the end of the study | 3 years | 
| Technical success rate of stent placement | Technical success rate of stent placement under digestive endoscopy defined by good progression of contrast through the stent into the gastric cavity after stent placement | 1 day | 
| Clinical success rate of stent placement on dysphagia | Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy) | 3 days | 
| Gastroesophageal reflux disease (GERD) after stent placement | Gastroesophageal reflux disease with the Reflux Disease Questionnaire (RDQ) score. The Reflux Disease Questionnaire a 12-item self-administered questionnaire, was designed to assess the frequency and severity of heartburn, regurgitation, and dyspeptic complaints and to facilitate the diagnosis of GERD. Minimum 12 : better outcome Maximum 72 : worse outcome | 1 month | 
| Stent placement complication : hemorrhage | Necessity of blood transfusion and/or endoscopic management | 7 days | 
| Stent placement complication : pain | Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain | 7 days | 
| Stent placement complication : pneumoperitoneum | Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent Migration, GastroEsophageal Cancer, Esophageal Stenosis, Esophageal cancer, Endoscopy