New self-expandable metal stent to relieve malignant esophageal strictures

Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

This test will try a new self-expandable metal stent to relieve swallowing problems in adults with incurable esophageal cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT06364553 on ClinicalTrials.gov

What this trial studies

This single-center prospective observational study will enroll 20 adults with malignant dysphagia to receive a new esophageal self-expandable metal stent for palliation. The design is non-randomized and outcomes will be compared to the center's historic esophageal stent database of over 1,000 patients. The primary focus is on safety (for example migration, perforation, bleeding) and efficacy in relieving dysphagia measured before and after stent placement. Exclusion criteria include very proximal lesions, tumor length over 14 cm, prior stent placement, uncorrected coagulopathy, esophageal motility disorders, and nitinol allergy, and follow-up will occur at Erasmus MC in Rotterdam.

Who should consider this trial

Good fit: Adults (≥18 years) with malignant obstruction of the esophagus or esophagogastric junction causing dysphagia, a life expectancy under 12 months, and no prior stent are ideal candidates.

Not a fit: Patients with potentially curable disease, prior esophageal stents, tumors longer than 14 cm, lesions within 2 cm of the upper esophageal sphincter, uncorrected coagulopathy, motility disorders, or nitinol allergy are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the stent could provide faster and more durable relief of swallowing difficulty with an acceptable safety profile.

How similar studies have performed: Self-expandable metal stents are an established palliative option for malignant dysphagia with many prior studies showing symptom relief, though device-specific performance and complication rates vary.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Rotterdam, South Holland

• Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Annemijn D I Maan

Conditions Oesophageal Cancer