Status:
RECRUITING
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
Lead Sponsor:
Société Française d'Endoscopie Digestive
Conditions:
Stent Migration
GastroEsophageal Cancer
Eligibility:
All Genders
18-91 years
Phase:
NA
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...
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 ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05431738
Start Date
September 1 2022
End Date
September 1 2025
Last Update
July 30 2024
Active Locations (1)
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1
French Society of Digestive Endoscopy
Paris, France, 75006