Indocyanine green dye in surgical treatment of laryngeal cancer: perfusion assessment to identify patients at risk for complications
Recruiting
- Conditions
- Laryngeal cancerLaryngeal carcinoma10027656
- Registration Number
- NL-OMON51076
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Proven carcinoma of the larynx
- > 18 years of age
- Undergo a PTL or STL with or without neck dissection or undergo neck
dissection for LC
- Informed consent
- Patients are mentally competent
Exclusion Criteria
- Partial laryngectomy
- Pregnancy
- Patients with known allergy against ICG or iodine/shellfish
- Patients with hyperthyroidism or thyroid gland adenoma
- Patients with dialysis dependent renal failure and/or kidney transplant
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Peak fluorescence (F), time to peak fluorescence (T) and time to half-peak<br /><br>fluorescence (T1/2) will be measured. As a reference point we will measure the<br /><br>peak fluorescence of normal mucosa of the pharynx. Perfusion data will be<br /><br>correlated with the development of PCF or wound healing problems within 4 weeks<br /><br>after surgery. A receiver operation curve will be computed to determine<br /><br>sensitivity and specificity of ICG-IOLA. We will determine cut off values for<br /><br>hypoperfusion by relating the development of wound healing problems or PCF<br /><br>within 4 weeks of surgery to each variable. </p><br>
- Secondary Outcome Measures
Name Time Method <p>We want to compare perfusion rate of PTL to perfusion rate in STL in order to<br /><br>create cut off values for both patient categories.</p><br>