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

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

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.

Study Overview

• Status: Recruiting
• Conditions: GastroEsophageal Cancer; Stent Migration
• Intervention / Treatment: Device: Gastroesophageal stent placement

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David KARSENTI, MD; Phone Number: +33603454293; Email: karsenti@club-internet.fr

Study Locations

• France
  • Paris, France, 75006
    • Recruiting
    • French Society of Digestive Endoscopy
    • Contact: David KARSENTI, MD; Phone Number: +33603454293; Email: karsenti.paris@gmail.com
    • Contact: Maira MORENO, PHD; Email: rechercheclinique@sfed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STENT WITH ANTI-MIGRATION DEVICE; Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech	Device: Gastroesophageal stent placement; A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Active Comparator: STENT WITHOUT ANTI-MIGRATION DEVICE; Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe	Device: Gastroesophageal stent placement; A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Intragastric migration rate at M1	Stent Intragastric migration rate at M1 confirmed on radiography or CT	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Intragastric migration rate at M3	Stent Intragastric migration rate at M3 confirmed on radiography or CT	3 months
Stent Intragastric migration rate at M6	Stent Intragastric migration rate at M6 confirmed on radiography or CT	6 months
Dysphagia recurrence at M1	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)	1 month
Dysphagia recurrence at M3	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)	3 months
Dysphagia recurrence at M6	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 months
Dysphagia-free survival time	Dysphagia-free survival time at the end of the study	3 years
Technical success rate of stent placement	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	1 day
Clinical success rate of stent placement on dysphagia	Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy)	3 days
Gastroesophageal reflux disease (GERD) after stent placement	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	1 month
Stent placement complication : hemorrhage	Necessity of blood transfusion and/or endoscopic management	7 days
Stent placement complication : pain	Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain	7 days
Stent placement complication : pneumoperitoneum	Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement	1 day

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopy; Esophageal cancer; Esophageal Stenosis; GastroEsophageal Cancer; Stent Migration
• Other Study ID Numbers: ANTIMIG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No