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

Launched by ERASMUS MEDICAL CENTER · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment called a self-expandable metal stent (SEMS) for patients with esophageal cancer who have difficulty swallowing, a condition known as dysphagia. The goal of the study is to see how safe and effective this stent is in relieving symptoms for patients with a blockage in their esophagus caused by cancer. The trial is designed for adults aged 18 and older who have been diagnosed with a non-curable esophageal obstruction and have a life expectancy of less than 12 months.

To participate, individuals must have significant trouble swallowing due to the cancer and provide written consent to join the study. However, certain people may not qualify, such as those who have had previous stents for the same issue or certain medical conditions that could complicate the procedure. Participants in this study can expect to undergo the placement of the stent, which may help improve their ability to eat and maintain their quality of life. The trial is not yet recruiting patients, but it aims to provide important insights into this treatment option for those facing serious challenges from esophageal cancer.

Gender

ALL

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.