Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Lymph Node Mapping in Esophageal Cancer: a Technical Feasibility Study
Completed
- Conditions
- Esophageal cancerGullet cancer100179901001799110043413
- Registration Number
- NL-OMON33445
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Resectable esophageal carcinoma
> 21 years
Exclusion Criteria
Significant renal, cardiac, or pulmonary disease (ASA III-IV)
History of iodine allergy or anaphylactic reactions to insect bites or medication Presence or history of hyperthyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Ergonomics and function of the NIRF imaging system - the NIRF imaging system<br /><br>must not interfere with the standard esophagectomy and lymphadenectomy<br /><br>procedure and should be used safely by the surgeon. Duration of data<br /><br>acquisition: ~30 minutes. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Identify draining lymph nodes within the allocated procedure (usually 4-6<br /><br>hours)</p><br>