Clinical trial · Interventional
Esophageal Multisegmented FCSEMS for Malignant Strictures
EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety concerns
Summary
Brief summary (as posted)
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia. Study design: Prospective observational nonrandomized clinical study. Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS. Primary end points: * Safety: complications and adverse events during follow-up with special attention to stent migration rates; * Efficacy: technical success of stent placement. Secondary end points: * Recurrent dysphagia including its cause; * Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up); * Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up); * Pain related to esophageal stent.
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 |
|---|---|---|---|
| Esophageal Stent Stenosis | — | UNRESOLVED | — |
| Oesophageal Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multisegmented fully covered self-expandable metal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FC-SEMS
- description
- Placement of multisegmented fully covered self-expandable metal stent
- interventionNames
- Device: Multisegmented fully covered self-expandable metal stent
Primary outcomes (2)
- measure
- Adverse events
- timeFrame
- 6 months
- description
- Adverse events during follow-up
- measure
- Technical success of stent placement
- timeFrame
- 1 day
- description
- Technical success of stent placement
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients; * Requiring treatment for dysphagia (Ogilvie score of 2-41); * Life expectancy of less than 12 months. Exclusion criteria: * Stenosis after laryngectomy; * Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter; * Esophageal fistula; * Tumor length of more than 14 cm; * Previous stent placement for the same condition; * Inappropriate cultural level and understanding of the study; * Coagulopathy; * Patients with eosinophilic esophagitis or an esophageal motility disorder; * Nickel titanium (Nitinol) allergy.
References
Publications (1)
- DERIVEDKoggel LM, Reijm AN, Lantinga MA, de Jong DJ, Rodrigues-Pinto E, Spaander MCW, Siersema PD. Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study. Gastrointest Endosc. 2024 Jun;99(6):1027-1031.e6. doi: 10.1016/j.gie.2024.01.045. Epub 2024 Feb 3. PMID 38316224