Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-91
SponsorSociété Française d'Endoscopie Digestive
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gastroesophageal stent placement
DeviceA gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: STENT WITH ANTI-MIGRATION DEVICEActive comparator 1 intervention
Group B: STENT WITHOUT ANTI-MIGRATION DEVICEActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stent Intragastric migration rate at M1
Stent Intragastric migration rate at M1 confirmed on radiography or CT
Time frame
1 monthSecondary outcomes
1
Stent Intragastric migration rate at M3
Stent Intragastric migration rate at M3 confirmed on radiography or CT
Time frame
3 months2
Stent Intragastric migration rate at M6
Stent Intragastric migration rate at M6 confirmed on radiography or CT
Time frame
6 months3
Dysphagia recurrence at M1
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)
Time frame
1 month4
Dysphagia recurrence at M3
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)
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov