Indocyanine green dye in surgical treatment of laryngeal cancer: perfusion assessment to identify patients at risk for complications

Indocyanine green dye in surgical treatment of laryngeal cancer: perfusion assessment to identify patients at risk for complications - Indocyanine green dye in surgical treatment of laryngeal cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51076

Enrollment

Registered

2022-06-15

Start date

2023-03-22

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal cancer Laryngeal carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Peak fluorescence (F), time to peak fluorescence (T) and time to half-peak fluorescence (T1/2) will be measured. As a reference point we will measure the peak fluorescence of normal mucosa of the pharynx. Perfusion data will be correlated with the development of PCF or wound healing problems within 4 weeks after surgery. A receiver operation curve will be computed to determine sensitivity and specificity of ICG-IOLA. We will determine cut off values for hypoperfusion by relating the development of wound healing problems or PCF within 4 weeks of surgery to each variable.	—

Measure

Time frame

Peak fluorescence (F), time to peak fluorescence (T) and time to half-peak fluorescence (T1/2) will be measured. As a reference point we will measure the peak fluorescence of normal mucosa of the pharynx. Perfusion data will be correlated with the development of PCF or wound healing problems within 4 weeks after surgery. A receiver operation curve will be computed to determine sensitivity and specificity of ICG-IOLA. We will determine cut off values for hypoperfusion by relating the development of wound healing problems or PCF within 4 weeks of surgery to each variable.

—

Secondary

Measure	Time frame
We want to compare perfusion rate of PTL to perfusion rate in STL in order to create cut off values for both patient categories.	—

Countries

Netherlands

Outcome results