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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05431738
Other study ID # ANTIMIG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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