NCT06831149

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Matthew Spector · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using Indocyanine green (ICG) angiography. In an observational study of 41 patients who underwent salvage TL with onlay free flap reconstruction, 7 (17%) patients developed PCF. Intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. In patients with ingress \<15 (n=25), 24% developed a PCF. In contrast, no PCF was seen in the group with ingress \>15. Of note, in patients with ingress \<15, there was no intervention performed as this was an observational study.

Conditions

• Squamous Cell Carcinoma
• Pharyngocutaneous Fistula

Interventions

Type	Name	Description
PROCEDURE	Removal of pharyngeal mucosa with decreased perfusion will be performed	Surgical removal of underperfused tissue versus nonremoval of tissue
DEVICE	SPY-PHI	SPY Portable Handheld Imaging (SPY-PHI)
DRUG	ICG (Indocyanine Green)	ICG will be used in conjunction with the SPY-PHI system for tissue imaging.

Timeline

• Start date: 2025-02-28
• Primary completion: 2028-02-28
• Completion: 2030-02-28
• First posted: 2025-02-17
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study