NL-OMON26240
Recruiting
N/A
A multicenter, prospective feasibility follow-up study to evaluate a fully covered stent with new antimigration properties for the palliation of malignant dysphagia: HANARO study.
niversity Medical Center Utrecht (UMCU), Departement of Gastronenterology and Hepatology0 sites40 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Esophageal cancer, Dysphagia, Palliation, Migration, Stent
- Sponsor
- niversity Medical Center Utrecht (UMCU), Departement of Gastronenterology and Hepatology
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Inoperable malignant obstruction of the esophagus or esophagogastric junction caused by esophageal or cardia carcinoma or extrinsic malignant compression. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease, OR;
- •2\. Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer;
Exclusion Criteria
- •1\. Evidence of tumor growth within 2 cm of the upper esophageal sphincter;
- •2\. A tumor covering \< 50% of the circumference;
Outcomes
Primary Outcomes
Not specified
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