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

NCT05431738 | Recruiting

• 1 other identifier: ANTIMIG
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

Conditions

Stent Migration; GastroEsophageal Cancer

Keywords

Stent Migration; GastroEsophageal Cancer; Esophageal Stenosis; Esophageal cancer; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Stent Intragastric migration rate at M1

  Stent Intragastric migration rate at M1 confirmed on radiography or CT

  1 month

Secondary Outcomes (12)

• Stent Intragastric migration rate at M3

  3 months

• Stent Intragastric migration rate at M6

  6 months

• Dysphagia recurrence at M1

  1 month

• Dysphagia recurrence at M3

  3 months

• Dysphagia recurrence at M6

  6 months

Study Arms (2)

STENT WITH ANTI-MIGRATION DEVICE

ACTIVE COMPARATOR

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

Device: Gastroesophageal stent placement

STENT WITHOUT ANTI-MIGRATION DEVICE

ACTIVE COMPARATOR

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

Device: Gastroesophageal stent placement

Interventions

Gastroesophageal stent placement DEVICE

A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

STENT WITH ANTI-MIGRATION DEVICE; STENT WITHOUT ANTI-MIGRATION DEVICE

Eligibility Criteria

• Age: 18 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

French Society of Digestive Endoscopy

Paris, 75006, France

RECRUITING

MeSH Terms

Conditions

Esophageal Stenosis; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Central Study Contacts

David KARSENTI, MD

CONTACT

+33603454293; karsenti@club-internet.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The stent is placed under endoscopy during general anesthesia. The type of stent is not specified in the endoscopy report. The patient is not informed of the type of esophageal stent placed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, controlled, randomized, multicentre, single-blind study.

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (1)