Status:
RECRUITING
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Conditions:
Surgery Site Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed. Sometimes part of the throat does not heal and...
Detailed Description
Salvage laryngectomy is associated with the highest morbidity and mortality in head and neck cancer patients. Pharyngocutaneous fistula is one of the most common surgical complication in the patient p...
Eligibility Criteria
Inclusion
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age \> 18 years, male or female.
- Patient must be undergoing salvage laryngectomy after radiation or chemoradiation. By definition, the patients are considered resectable by the treating head and neck surgeon.
- The expected pharyngeal defect must be conducive to imaging with the ICG.
- Vascularized tissue augmentation (flap) is part of the operative plan (supra- or infraclavicular flap excludes the patient).
- ECOG performance status 0-2.
Exclusion
- Total Laryngopharyngectomy
- On immune suppression medications
- Current hematologic malignancy
- Pregnancy
- Allergy to Iodine
- TSH greater than 8
- BMI less than 18
- Vascularized augmentation is a supra or infraclavicular rotational flap
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05350540
Start Date
November 11 2021
End Date
November 1 2028
Last Update
June 2 2022
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4