Actively Recruiting
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
Led by University Health Network, Toronto · Updated on 2022-06-02
70
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
S
Sunnybrook Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 saliva runs out of the throat. This is called a fistula. When a fistula happens, healing takes longer and patients will have to wait to eat and start speaking. The test in this research project is called ICG scan (indocyanine green) and tells the surgeon how much blood is flowing to different parts of the throat. If the test shows that there are parts of your throat that have low blood flow, which will delay healing. Only half of the patients in the study will get the ICG scan. This is so the patients who had the ICG scan can be compared to the patients that did not have the ICG scan to determine if the ICG scan really helps decrease fistulas.
CONDITIONS
Official Title
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written and voluntary informed consent
- Willing and able to comply with study visits, treatment, lab tests, and procedures
- Age over 18 years, male or female
- Undergoing salvage laryngectomy after radiation or chemoradiation and considered resectable by surgeon
- Expected pharyngeal defect suitable for imaging with ICG
- Vascularized tissue flap planned for reconstruction (excluding supra- or infraclavicular flaps)
- ECOG performance status between 0 and 2
You will not qualify if you...
- Total laryngopharyngectomy
- Use of immune suppression medications
- Current hematologic malignancy
- Pregnancy
- Allergy to iodine
- Thyroid stimulating hormone (TSH) level greater than 8
- Body mass index (BMI) less than 18
- Use of supra- or infraclavicular rotational flap for vascularized augmentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
D
Douglas Chepeha, MD
CONTACT
A
Alex Esemezie, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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