Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stent Migration
- Sponsor
- Société Française d'Endoscopie Digestive
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Stent Intragastric migration rate at M1
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
KARSENTI
Principal Investigator
Société Française d'Endoscopie Digestive
Eligibility Criteria
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
Outcomes
Primary Outcomes
Stent Intragastric migration rate at M1
Time Frame: 1 month
Stent Intragastric migration rate at M1 confirmed on radiography or CT
Secondary Outcomes
- Dysphagia recurrence at M3(3 months)
- Gastroesophageal reflux disease (GERD) after stent placement(1 month)
- Stent placement complication : hemorrhage(7 days)
- Clinical success rate of stent placement on dysphagia(3 days)
- Stent Intragastric migration rate at M3(3 months)
- Dysphagia-free survival time(3 years)
- Stent Intragastric migration rate at M6(6 months)
- Dysphagia recurrence at M1(1 month)
- Dysphagia recurrence at M6(6 months)
- Technical success rate of stent placement(1 day)
- Stent placement complication : pain(7 days)
- Stent placement complication : pneumoperitoneum(1 day)