Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Spector

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Removal of pharyngeal mucosa with decreased perfusion will be performed

    Procedure/Surgery

    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.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Patients having salvage TL after failure with radiation or chemoradiationOther 3 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From enrollment through 1 month post surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew Spector

Lead sponsor

University of Pittsburgh

Sponsor institution