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

Last updated: July 27, 2024
Sponsor: Société Française d'Endoscopie Digestive
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Gastroesophageal stent placement

Clinical Study ID

NCT05431738
ANTIMIG
  • Ages 18-91
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient of both sexes aged 18 or over.

  2. Patient admitted to one of the investigation centers for dysphagia due to tumoralstenosis 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

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 theintroduction 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

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Gastroesophageal stent placement
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • French Society of Digestive Endoscopy

    Paris, 75006
    France

    Active - Recruiting

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