Clinical trial · Interventional
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
NCT05431738CI-TRIAL-00079226ANTIMIGunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GastroEsophageal Cancer | — | UNRESOLVED | — |
| Stent Migration | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gastroesophageal stent placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- STENT WITH ANTI-MIGRATION DEVICE
- description
- Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech
- interventionNames
- Device: Gastroesophageal stent placement
- type
- ACTIVE_COMPARATOR
- label
- STENT WITHOUT ANTI-MIGRATION DEVICE
- description
- Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe
- interventionNames
- Device: Gastroesophageal stent placement
Primary outcomes (1)
- measure
- Stent Intragastric migration rate at M1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 91 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.