Comparing two types of esophageal stents for cancer treatment
Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
This study is testing if a special type of esophageal stent with an anti-migration device can help people with esophageal cancer have fewer problems and better outcomes than a regular stent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 91 Years |
| Sex | All |
| Sponsor | Société Française d'Endoscopie Digestive Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05431738 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an anti-migration device in reducing the rate of intragastric migration of esophageal stents used for patients with locally advanced or metastatic gastroesophageal junction tumors. It is a prospective, controlled, randomized, multicentre, single-blind study that compares two types of stents: one with the anti-migration device and one without. The study will assess not only the migration rates but also the morbidity, effectiveness on dysphagia and reflux, and overall survival duration without dysphagia. The findings could provide valuable insights into improving stent placement outcomes for patients with esophageal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with dysphagia due to malignant stenosis of the gastroesophageal junction.
Not a fit: Patients with stenosis caused by extrinsic compression or those with severe comorbidities (ASA 4 or 5) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stent retention and reduced complications for patients with gastroesophageal cancer.
How similar studies have performed: While pilot studies suggest the anti-migration device is safe, this is the first comparative study to evaluate its effectiveness, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- French Society of Digestive Endoscopy — Paris, France (Recruiting)
Study contacts
- Study coordinator: David KARSENTI, MD
- Email: karsenti@club-internet.fr
- Phone: +33603454293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.