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Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech

Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe

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

Gastroesophageal stent placement

David KARSENTI, MD

Maira MORENO, PHD

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.

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.

This is a prospective, controlled, randomized, multicentre, single-blind study.

The stent is placed under endoscopy during general anesthesia. The type of stent is not specified in the endoscopy report. The patient is not informed of the type of esophageal stent placed.

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

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

Stent Intragastric migration rate at M1 confirmed on radiography or CT

Stent Intragastric migration rate at M3 confirmed on radiography or CT

Stent Intragastric migration rate at M6 confirmed on radiography or CT

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

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

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

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

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

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

Dysphagia-free survival time at the end of the study

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

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

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

Necessity of blood transfusion and/or endoscopic management

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)	NCT05431738	Stent Migration GastroEsophagea...	Gastroesophagea...	18 Years - 91 Years	Société Française d'Endoscopie Digestive
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)	NCT05431738	Stent Migration GastroEsophagea...	Gastroesophagea...	18 Years - 91 Years	Société Française d'Endoscopie Digestive

Spots Global Cancer Trial Database for gastroesophageal stent placement