Safety and efficacy of a biodegradable stent during neoadjuvant therapy in patients with advanced esophageal cancer.
Completed
- Conditions
- esophageal cancer1001799010017991
- Registration Number
- NL-OMON36667
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
* cT1-3 N0-1 M0 esophageal carcinoma.
* Scheduled for neoadjuvant chemoradiation therapy prior to esophagectomy.
* Dysphagia for solid, semisolid or liquid food (dysphagia score 2, 3, 4).
* Age older then 18 years.
* Informed consent.
Exclusion Criteria
* Tumor length of more than 10 cm.
* Tumor growth within 5 cm of the upper esophageal sphincter.
* Tumor extension into the stomach more than 5 cm.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is safety. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are clinical succes, technical success, persistent<br /><br>or recurrent dysphagia, complications and weight changes. </p><br>