GastroEsophageal Cancer Clinical Trial
— ANTIMIGOfficial title:
Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | French Society of Digestive Endoscopy | Paris |
Lead Sponsor | Collaborator |
---|---|
Société Française d'Endoscopie Digestive |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04544046 -
Supportive Oncology Care At Home RCT
|
N/A | |
Not yet recruiting |
NCT04555304 -
Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
|
Phase 2 | |
Terminated |
NCT02669914 -
MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
|
Phase 2 | |
Completed |
NCT04099641 -
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
|
Phase 2 | |
Recruiting |
NCT04385641 -
Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
|
N/A | |
Completed |
NCT03165994 -
APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
|
Phase 2 | |
Active, not recruiting |
NCT03279237 -
A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers
|
Phase 1 | |
Completed |
NCT03321630 -
A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
|
Phase 2 | |
Completed |
NCT02853474 -
Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy
|
Phase 3 | |
Recruiting |
NCT05620134 -
Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03983954 -
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT06138223 -
The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
|
N/A | |
Active, not recruiting |
NCT03647969 -
Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05122091 -
Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma
|
Phase 2 | |
Completed |
NCT03720678 -
A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
|
Phase 1 | |
Completed |
NCT02317991 -
Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer
|
Phase 2 | |
Completed |
NCT02013154 -
A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
|
Phase 1 | |
Terminated |
NCT05395052 -
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06356311 -
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
|
Phase 3 | |
Active, not recruiting |
NCT03490292 -
Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer
|
Phase 1/Phase 2 |