RecruitingPhase 2NCT06831149

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


Sponsor

Matthew Spector

Enrollment

225 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special imaging system called SPY (which uses a dye and infrared light to check blood supply to tissue during surgery) can help reduce a serious complication called a fistula — an abnormal opening in the throat — after surgery to remove a larynx (voice box) that has been damaged by cancer or radiation. **You may be eligible if...** - You have a confirmed diagnosis of squamous cell carcinoma of the larynx or throat area (stage II–IV) - You have previously been treated with radiation, with or without chemotherapy - You have local cancer recurrence, radiation-related tissue damage, or a larynx that no longer functions properly - You are 18 years or older **You may NOT be eligible if...** - You are allergic to iodine or shellfish - You cannot safely undergo general anesthesia - You are pregnant or breastfeeding - You are currently incarcerated Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURERemoval of pharyngeal mucosa with decreased perfusion will be performed

Surgical removal of underperfused tissue versus nonremoval of tissue

DEVICESPY-PHI

SPY Portable Handheld Imaging (SPY-PHI)

DRUGICG (Indocyanine Green)

ICG will be used in conjunction with the SPY-PHI system for tissue imaging.


Locations(1)

UPMC

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06831149


Related Trials