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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
French Society of Digestive Endoscopy
Paris, France
RECRUITINGStent Intragastric migration rate at M1
Stent Intragastric migration rate at M1 confirmed on radiography or CT
Time frame: 1 month
Stent Intragastric migration rate at M3
Stent Intragastric migration rate at M3 confirmed on radiography or CT
Time frame: 3 months
Stent Intragastric migration rate at M6
Stent Intragastric migration rate at M6 confirmed on radiography or CT
Time frame: 6 months
Dysphagia recurrence at M1
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)
Time frame: 1 month
Dysphagia recurrence at M3
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)
Time frame: 3 months
Dysphagia recurrence at M6
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)
Time frame: 6 months
Dysphagia-free survival time
Dysphagia-free survival time at the end of the study
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Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 1 month
Stent placement complication : hemorrhage
Necessity of blood transfusion and/or endoscopic management
Time frame: 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
Time frame: 7 days
Stent placement complication : pneumoperitoneum
Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement
Time frame: 1 day