GastroEsophageal Cancer, Stent Migration
Conditions
Keywords
Stent Migration, GastroEsophageal Cancer, Esophageal Stenosis, Esophageal cancer, Endoscopy
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.
Interventions
DEVICEGastroesophageal stent placement
A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control
Sponsors
Société Française d'Endoscopie Digestive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
This is a prospective, controlled, randomized, multicentre, single-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 91 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent Intragastric migration rate at M1 | 1 month | Stent Intragastric migration rate at M1 confirmed on radiography or CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Intragastric migration rate at M6 | 6 months | Stent Intragastric migration rate at M6 confirmed on radiography or CT |
| Dysphagia recurrence at M1 | 1 month | 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 recurrence at M3 | 3 months | 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 recurrence at M6 | 6 months | 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 | 3 years | Dysphagia-free survival time at the end of the study |
| Stent Intragastric migration rate at M3 | 3 months | Stent Intragastric migration rate at M3 confirmed on radiography or CT |
| Clinical success rate of stent placement on dysphagia | 3 days | Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy) |
| Gastroesophageal reflux disease (GERD) after stent placement | 1 month | 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 |
| Stent placement complication : hemorrhage | 7 days | Necessity of blood transfusion and/or endoscopic management |
| Stent placement complication : pain | 7 days | Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain |
| Stent placement complication : pneumoperitoneum | 1 day | Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement |
| Technical success rate of stent placement | 1 day | 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 |
Countries
France
Contacts
Primary ContactDavid KARSENTI, MD
Outcome results
None listed