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Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

RecruitingPhase 2Ages 18 Years - anyAllMatthew Spector
NCT06831149 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV) 2. Prior treatment with radiation +/- chemotherapy 3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx 4. 18 years or older. 5. Ability to understand and sign informed consent Exclusion Criteria: 1. Iodine and Shellfish allergy 2. Contraindication to surgery under general anesthesia 3. 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 4. Pregnancy or lactation. 5. Patients residing in prison.
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What it tests

  • Removal of pharyngeal mucosa with decreased perfusion will be performed
  • SPY-PHI
  • ICG (Indocyanine Green)
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Where

1 site
UPMC
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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