RecruitingNot ApplicableNCT06364553

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

Sponsor

Erasmus Medical Center

Enrollment

30 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Oesophageal Cancer

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

Interventions

DEVICEEsophageal self-expandable metal stent

The Leufen Esophageal aixstent ® (Leufen Medical GmbH) is indicated for the treatment of malignant esophageal strictures and postoperative stenosis. It is comprised of two components: an implantable metallic stent and the delivery system. After the procedure, the stent remains at the intended location, within the patient while the delivery system is removed.