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NCT Number: NCT06831149

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

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.

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Pharyngocutaneous Fistula Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Matthew E Spector, MD

CONTACT

[email protected]

412-647-2100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
  • Prior treatment with radiation +/- chemotherapy
  • Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
  • 18 years or older. 5. Ability to understand and sign informed consent

Exclusion criteria

  • Iodine and Shellfish allergy
  • Contraindication to surgery under general anesthesia
  • Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery
  • Pregnancy or lactation.
  • Patients residing in prison.

Treatment and study plan

Removal of pharyngeal mucosa with decreased perfusion will be performed

Procedure

Surgical removal of underperfused tissue versus nonremoval of tissue

SPY-PHI

Device

SPY Portable Handheld Imaging (SPY-PHI)

ICG (Indocyanine Green)

Drug

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

Primary outcomes

  1. Incidence of PCF, within one month post total laryngectomy (TL)

    Time frame: From enrollment through 1 month post surgery

    Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew E Spector, MD

CONTACT

[email protected]

412-647-2100

Sponsors and collaborators

Lead sponsor

Matthew Spector

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Feb 17, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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