Recruiting
Phase 2

ICG

Sponsor:

University Health Network, Toronto

Code:

NCT05350540

Conditions

Surgery Site Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ICG dye

Study Details

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 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

Surgery Site Fistula

Study ID

NCT05350540

Start date

Nov 11, 2021

Status verified date

May, 2022

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICG

This study will use intraoperative ICG imaging to assess recipient pharyngeal tissue perfusion. The ICG is the vascular contrast agent and the SPY Elite is the imaging device. 3mL of ICG will be injected using a peripheral IV access, followed by a 10mL saline flush. The pharyngeal mucosa will be imaged to quantify the tissue perfusion. Poorly perfused areas (less than 25%) will be debrided

no intervention: Control

Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa

Interventions

ICG dye

Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging

Primary outcome measure

  • ICG Perfusion [ Time Frame: Collected at time of surgery ]
  • Surgical Complications [ Time Frame: Collected up to 1 week after hospital discharge ]

Central Contacts and Locations

Central contacts

Douglas Chepeha, MD

(416) 340-3082douglas.chepeha@uhn.ca

Alex Esemezie, BSc

(416) 340-4800alex.esemezie@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Alex Esemezie, BSc

(416) 340-4800alex.esemezie@uhn.ca

Principal Investigator:

Douglas Chepeha, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 2, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-06-02.