EsophageAl mulTisegmented fully covERed self-expandable metal Stent for malignant strictures: a Safety and Feasibility study

Phase 4

Completed

• Conditions: Esophageal cancer; malignant dysphagia; 10018008

• Registration Number: NL-OMON55233
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-07-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Patients presenting with dysphagia due to a non-operable 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 2-4);
- 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;
- Esophageal fistula;
- Previous stent placement for the same condition;
- Inappropriate cultural level and understanding of the study;
- Coagulopathy;
- Patients with eosinophilic esophagitis or a esohpageal motility disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified