RECRUITING

Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-28
Study Completion:2030-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06831149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
  2. 2. Prior treatment with radiation +/- chemotherapy
  3. 3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
  4. 4. 18 years or older. 5. Ability to understand and sign informed consent
  1. 1. Iodine and Shellfish allergy
  2. 2. Contraindication to surgery under general anesthesia
  3. 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. 4. Pregnancy or lactation.
  5. 5. Patients residing in prison.

Contacts and Locations

Study Contact

Matthew E Spector, MD
CONTACT
412-647-2100
spectorme@upmc.edu

Principal Investigator

Matthew E Spector, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh/UPMC

Study Locations (Sites)

UPMC
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Matthew Spector

  • Matthew E Spector, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh/UPMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28
Study Completion Date2030-02-28

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2030-02-28

Terms related to this study

Keywords Provided by Researchers

  • squamous cell carcinoma hypopharynx
  • squamous cell carcinoma larynx
  • SPY Fluorescence Imaging System

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma
  • Pharyngocutaneous Fistula