New self-expandable metal stent to relieve malignant esophageal strictures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Annemijn D I Maan
• Email: a.maan@erasmusmc.nl
• Phone: +31653305615

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.