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

Société Française d'Endoscopie Digestive

Status: Enrolling

Conditions: GastroEsophageal Cancer; Stent Migration

Treatments: Device: Gastroesophageal stent placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05431738

ANTIMIG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 91 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient of both sexes aged 18 or over.
2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis 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 criteria

1. Patient referred for stenosis by extrinsic compression by an extra digestive mass
2. Patients with contraindications relating to the procedures essential for the introduction 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

STENT WITH ANTI-MIGRATION DEVICE

Active Comparator group

Description:

Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech

Treatment:

Device: Gastroesophageal stent placement

STENT WITHOUT ANTI-MIGRATION DEVICE

Active Comparator group

Description:

Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe

Treatment:

Device: Gastroesophageal stent placement