RECRUITING · INTERVENTIONAL · TREATMENT study · Squamous Cell Carcinoma · Phase 2 · Enrollment 225 · Sponsor: Matthew Spector
Official title: A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction
Summary: Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food. The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery. For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens. Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.
Conditions: Squamous Cell Carcinoma, Pharyngocutaneous Fistula
Keywords: squamous cell carcinoma hypopharynx, squamous cell carcinoma larynx, SPY Fluorescence Imaging System
Study type: INTERVENTIONAL
Primary purpose: TREATMENT
Phases: PHASE2
Enrollment: 225 (ESTIMATED)
Status: RECRUITING
Completion: 2030-02-28 (ESTIMATED)