Clinical trial NCT05431738: Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
Official title: Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stent Migration
GastroEsophageal Cancer
Keywords: Stent Migration
GastroEsophageal Cancer
Esophageal Stenosis
Esophageal cancer
Endoscopy
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, controlled, randomized, multicentre, single-blind study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stent Intragastric migration rate at M1
timeFrame: 1 month
Secondary outcomes:
measure: Stent Intragastric migration rate at M3
timeFrame: 3 months
measure: Stent Intragastric migration rate at M6
timeFrame: 6 months
measure: Dysphagia recurrence at M1
timeFrame: 1 month
measure: Dysphagia recurrence at M3
timeFrame: 3 months
measure: Dysphagia recurrence at M6
timeFrame: 6 months
measure: Dysphagia-free survival time
timeFrame: 3 years
measure: Technical success rate of stent placement
timeFrame: 1 day
measure: Clinical success rate of stent placement on dysphagia
timeFrame: 3 days
measure: Gastroesophageal reflux disease (GERD) after stent placement
timeFrame: 1 month
measure: Stent placement complication : hemorrhage
timeFrame: 7 days
measure: Stent placement complication : pain
timeFrame: 7 days
measure: Stent placement complication : pneumoperitoneum
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: French Society of Digestive Endoscopy
Study officials:
References: