RecruitingNot Applicable

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

France180 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range18 Years – 91 Years

SexALL

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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

What they're measuring

Stent Intragastric migration rate at M1

Timeframe: 1 month

Trial details

NCT IDNCT05431738

SponsorSociété Française d'Endoscopie Digestive

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

David KARSENTI, MD

+33603454293 karsenti@club-internet.fr

View on ClinicalTrials.gov More Stent Migration trials