Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Recruiting now · Not applicable
Conditions studied: Oesophageal Cancer
In brief
A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
Key facts
- Study ID
- NCT06364553
- Run by
- Erasmus Medical Center
- People needed
- 30
- Starts
- 2024-10-02
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients presenting with dysphagia due to a non-curable 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;
- Written informed consent;
- Age ≥ 18 years.
You may not qualify if…
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Coagulopathy (not corrected prior to stent placement);
- Patients with eosinophilic esophagitis or an esophageal motility disorder;
- Nickel titanium (Nitinol) allergy.
Where it is running
- Erasmus MC — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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