Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Incidence of PCF, within one month post total laryngectomy (TL) [Time frame: From enrollment through 1 month post surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• UPMC — Pittsburgh

Identifiers

NCT: NCT06831149 · STUDY24100162

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗