Using ICG imaging to reduce throat healing complications after laryngectomy
Randomized Phase II Study to Compare Intraoperative Indocyanine Green (ICG) Imaging and Guided Mucosal Debridement vs Observation (Standard of Care) to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
This study is testing if using a special imaging technique during throat surgery can help prevent healing problems and improve recovery for patients who have had a laryngectomy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05350540 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of indocyanine green (ICG) imaging to assess blood flow in the throat during salvage laryngectomy procedures. The study aims to determine if ICG imaging can help identify areas of low blood flow, which may lead to complications such as pharyngocutaneous fistula. Half of the participants will receive the ICG scan, while the other half will not, allowing for a comparison of outcomes between the two groups. The goal is to reduce the incidence of fistulas and improve healing times for patients undergoing this surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing salvage laryngectomy after radiation or chemoradiation.
Not a fit: Patients who are undergoing total laryngopharyngectomy or have certain medical conditions, such as current hematologic malignancy or pregnancy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of surgical complications and improve recovery times for patients undergoing laryngectomy.
How similar studies have performed: Previous studies have shown that ICG imaging can effectively reduce complications in other surgical contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written and voluntary informed consent. * Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. * Age \> 18 years, male or female. * Patient must be undergoing salvage laryngectomy after radiation or chemoradiation. By definition, the patients are considered resectable by the treating head and neck surgeon. * The expected pharyngeal defect must be conducive to imaging with the ICG. * Vascularized tissue augmentation (flap) is part of the operative plan (supra- or infraclavicular flap excludes the patient). * ECOG performance status 0-2. Exclusion Criteria: * Total Laryngopharyngectomy * On immune suppression medications * Current hematologic malignancy * Pregnancy * Allergy to Iodine * TSH greater than 8 * BMI less than 18 * Vascularized augmentation is a supra or infraclavicular rotational flap
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Douglas Chepeha, MD
- Email: douglas.chepeha@uhn.ca
- Phone: (416) 340-3082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.