Palliatie bij slokdarmcarcinoom Brachytherapie Biodegradable stent Pallation for inoperable esophageal cancer Brachytherpy Biodegradable stent
Conditions
Interventions
Patients will be given a BD-ELLA stent in combination with single dose brachytherapy (12Gy).
Sponsors
UMC Utrecht,
Department of Gastroenterology and Hepatology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inoperable cancer of the esophagus or esophagogastric junction due to locally advanced disease, metastatic disease (as defined by TNM classification) or poor medical condition; 2. Prognostic score ¡Ü5* (in order to benefit from brachytherapy effect); 3. Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie(30) appendix 1); 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with T4, N0-1, M0 in good clinical health, who will be treated with radiation and/ or chemotherapy; 2. Tumour length of more than 10 cm; 3. Tumour growth within 2 cm of the upper esophageal sphincter; 4. Deep ulceration; 5. Tracheo-esophageal fistula; 6. Macroscopic or microscopic tumour growth into the tracheal lumen; 7. Previous radiation or stent placement; 8. Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major and minor complications and technical success rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Persistent and recurrent dysphagia. | — |
Contacts
Public ContactM.M.C. Hirdes
P.O. Box 85500, 3508 GA Utrecht
Outcome results
None listed