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

Last updated: August 4, 2025
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Cancer

Treatment

Esophageal self-expandable metal stent

Clinical Study ID

NCT06364553
NL86416.078.24
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients presenting with dysphagia due to a non-curable malignant obstruction of theesophagus or esophagogastric junction including extrinsic malignant compression andrecurrence 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

Exclusion Criteria:

  • Stenosis after laryngectomy;

  • Distance between the upper edge of the stent less than 2 cm from the upperesophageal 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.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Esophageal self-expandable metal stent
Phase:
Study Start date:
October 02, 2024
Estimated Completion Date:
October 01, 2025

Study Description

Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

Connect with a study center

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Active - Recruiting

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