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

Not Applicable

Recruiting

• Conditions: Stent Migration; GastroEsophageal Cancer
• Interventions: Device: Gastroesophageal stent placement

• Registration Number: NCT05431738
• Lead Sponsor: Société Française d'Endoscopie Digestive

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.

Study Timeline

• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-19
• Study First Posted: 2022-06-24
• Study Start: 2022-09-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patient of both sexes aged 18 or over.
2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
3. Patient ASA 1, ASA 2, ASA 3
4. Absence of participation in another clinical study
5. Signed Informed Consent
6. Patients benefiting from the social security system.

Exclusion Criteria

1. Patient referred for stenosis by extrinsic compression by an extra digestive mass
2. Patients with contraindications relating to the procedures essential for the introduction of a stent
3. Mediastinal radiotherapy or esophageal surgery history
4. Patient under 18 or over 90
5. Patient ASA 4, ASA 5
6. Pregnant Woman
7. Patient unable to give personal consent
8. Absence of signed informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STENT WITH ANTI-MIGRATION DEVICE	Gastroesophageal stent placement	Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech
STENT WITHOUT ANTI-MIGRATION DEVICE	Gastroesophageal stent placement	Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe

Primary Outcome Measures

Name	Time	Method
Stent Intragastric migration rate at M1	1 month	Stent Intragastric migration rate at M1 confirmed on radiography or CT

Secondary Outcome Measures

Name	Time	Method
Dysphagia recurrence at M3	3 months	Dysphagia evaluation in 5 stages (Atkinson score) at M3 0 - no dysphagia; 1. - Clinging to the swallowing of solids; 2. - Semi-liquid feeding possible; 3. - Liquid feeding possible; 4. - Aphagia (need for parenteral nutrition)
Gastroesophageal reflux disease (GERD) after stent placement	1 month	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
Stent placement complication : hemorrhage	7 days	Necessity of blood transfusion and/or endoscopic management
Clinical success rate of stent placement on dysphagia	3 days	Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy)
Stent Intragastric migration rate at M3	3 months	Stent Intragastric migration rate at M3 confirmed on radiography or CT
Dysphagia-free survival time	3 years	Dysphagia-free survival time at the end of the study
Stent Intragastric migration rate at M6	6 months	Stent Intragastric migration rate at M6 confirmed on radiography or CT
Dysphagia recurrence at M1	1 month	Dysphagia evaluation in 5 stages (Atkinson score) at M1 0 - no dysphagia; 1. - Clinging to the swallowing of solids; 2. - Semi-liquid feeding possible; 3. - Liquid feeding possible; 4. - Aphagia (need for parenteral nutrition)
Dysphagia recurrence at M6	6 months	Dysphagia evaluation in 5 stages (Atkinson score) at M6 0 - no dysphagia; 1. - Clinging to the swallowing of solids; 2. - Semi-liquid feeding possible; 3. - Liquid feeding possible; 4. - Aphagia (need for parenteral nutrition)
Technical success rate of stent placement	1 day	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
Stent placement complication : pain	7 days	Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain
Stent placement complication : pneumoperitoneum	1 day	Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement

Trial Locations

Locations (1)

French Society of Digestive Endoscopy; 🇫🇷 Paris, France