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
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed. Sometimes part of the throat does not heal and saliva runs out of the throat. This is called a fistula. When a fistula happens, healing takes longer and patients will have to wait to eat and start speaking. The test in this research project is called ICG scan (indocyanine green) and tells the surgeon how much blood is flowing to different parts of the throat. If the test shows that there are parts of your throat that have low blood flow, which will delay healing. Only half of the patients in the study will get the ICG scan. This is so the patients who had the ICG scan can be compared to the patients that did not have the ICG scan to determine if the ICG scan really helps decrease fistulas.
• 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.