Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Apr 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients heal after a laryngectomy, which is surgery to remove the voice box due to conditions like cancer. After the surgery, some patients develop a problem called a fistula, where saliva leaks from the throat because it hasn't healed properly. The researchers are testing a special scan called ICG (indocyanine green) that helps the surgeon see how well blood is flowing to the throat. Better blood flow can mean better healing. In this study, only half of the patients will receive the ICG scan, allowing the researchers to compare the healing success between those who had the scan and those who did not.

To participate in the trial, you must be an adult over 18 years old who is having a salvage laryngectomy after previous treatments like radiation. You should also be able to follow the study's requirements, including attending scheduled visits and treatments. Not everyone can join; for instance, if you are pregnant, have certain health conditions, or are on specific medications, you may be excluded. If you join the trial, you’ll be closely monitored to see how well you heal and whether the ICG scan helps reduce the chances of developing a fistula. This could lead to quicker recovery times and a better quality of life after surgery.

Gender

ALL

Eligibility 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