Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy

NCT05350540 | Recruiting Phase 2

• 1 other identifier: 20-5419
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• ICG Perfusion

  Perfusion of the mucosa after the administration of ICG will be recorded.

  Collected at time of surgery

• Surgical Complications

  The complications the study participants experience post-surgically, if any, will be recorded.

  Collected up to 1 week after hospital discharge

Secondary Outcomes (3)

• Disease Status

  Collected at times week 1, 3 months, 6 months, and 12 months

• Laryngeal Rehabilitation

  Collected at times week 1, 3 months, 6 months, and 12 months

• Speech and Swallowing Questionnaire

  Administered at times week 1, 3 months, 6 months, and 12 months

Study Arms (2)

ICG

EXPERIMENTAL

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

Other: ICG dye

Control

NO INTERVENTION

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

Interventions

ICG dye OTHER

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

ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Central Study Contacts

Douglas Chepeha, MD

CONTACT

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

Alex Esemezie, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 28, 2022
• Study Start: November 11, 2021
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CA (1)