Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05431738

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stent Migration Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Stenosis GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastroesophageal stent placement

Device

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

Primary outcomes

  1. Stent Intragastric migration rate at M1

    Time frame: 1 month

    Stent Intragastric migration rate at M1 confirmed on radiography or CT

Secondary outcomes

  1. Stent Intragastric migration rate at M3

    Time frame: 3 months

    Stent Intragastric migration rate at M3 confirmed on radiography or CT

  2. Stent Intragastric migration rate at M6

    Time frame: 6 months

    Stent Intragastric migration rate at M6 confirmed on radiography or CT

  3. Dysphagia recurrence at M1

    Time frame: 1 month

    Dysphagia evaluation in 5 stages (Atkinson score) at M1 0 - no dysphagia

    • - Clinging to the swallowing of solids
    • - Semi-liquid feeding possible
    • - Liquid feeding possible
    • - Aphagia (need for parenteral nutrition)

  4. Dysphagia recurrence at M3

    Time frame: 3 months

    Dysphagia evaluation in 5 stages (Atkinson score) at M3 0 - no dysphagia

    • - Clinging to the swallowing of solids
    • - Semi-liquid feeding possible
    • - Liquid feeding possible
    • - Aphagia (need for parenteral nutrition)

  5. Dysphagia recurrence at M6

    Time frame: 6 months

    Dysphagia evaluation in 5 stages (Atkinson score) at M6 0 - no dysphagia

    • - Clinging to the swallowing of solids
    • - Semi-liquid feeding possible
    • - Liquid feeding possible
    • - Aphagia (need for parenteral nutrition)

  6. Dysphagia-free survival time

    Time frame: 3 years

    Dysphagia-free survival time at the end of the study

  7. Technical success rate of stent placement

    Time frame: 1 day

    Technical success rate of stent placement under digestive endoscopy defined by good progression of contrast through the stent into the gastric cavity after stent placement

  8. Clinical success rate of stent placement on dysphagia

    Time frame: 3 days

    Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy)

  9. Gastroesophageal reflux disease (GERD) after stent placement

    Time frame: 1 month

    Gastroesophageal reflux disease with the Reflux Disease Questionnaire (RDQ) score. The Reflux Disease Questionnaire a 12-item self-administered questionnaire, was designed to assess the frequency and severity of heartburn, regurgitation, and dyspeptic complaints and to facilitate the diagnosis of GERD. Minimum 12 : better outcome Maximum 72 : worse outcome

  10. Stent placement complication : hemorrhage

    Time frame: 7 days

    Necessity of blood transfusion and/or endoscopic management

  11. Stent placement complication : pain

    Time frame: 7 days

    Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain

  12. Stent placement complication : pneumoperitoneum

    Time frame: 1 day

    Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement

Study contacts

Contact information is provided by the study sponsor or research team.

David KARSENTI, MD

CONTACT

[email protected]

+33603454293

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study

Acronym: ANTIMIG

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.