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

Erasmus University

Status

Enrolling

Conditions

Oesophageal Cancer

Treatments

Device: Esophageal self-expandable metal stent

Study type

Interventional

Funder types

Other

Identifiers

NCT06364553

NL86416.078.24

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.