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

GastroEsophageal Cancer Clinical Trial

— ANTIMIG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05431738
• Other study ID #: ANTIMIG
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2022
• Source: Société Française d'Endoscopie Digestive
• Contact: David KARSENTI, MD
• Phone: +33603454293
• Email: karsenti[@]club-internet.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 91 Years

Eligibility

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

Related Conditions & MeSH terms

• GastroEsophageal Cancer
• Stent Migration

Intervention

Device:
• Gastroesophageal stent placement
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

Locations

Country	Name	City	State
France	French Society of Digestive Endoscopy	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent Intragastric migration rate at M1	Stent Intragastric migration rate at M1 confirmed on radiography or CT	1 month
Secondary	Stent Intragastric migration rate at M3	Stent Intragastric migration rate at M3 confirmed on radiography or CT	3 months
Secondary	Stent Intragastric migration rate at M6	Stent Intragastric migration rate at M6 confirmed on radiography or CT	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Dysphagia-free survival time	Dysphagia-free survival time at the end of the study	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Stent placement complication : hemorrhage	Necessity of blood transfusion and/or endoscopic management	7 days
Secondary	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
Secondary	Stent placement complication : pneumoperitoneum	Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement	1 day