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RECRUITING
NCT05350540
PHASE2

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Randomized Phase II Study to Compare Intraoperative Indocyanine Green (ICG) Imaging and Guided Mucosal Debridement vs Observation (Standard of Care) to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-11-11

Completion Date

2028-11

Last Updated

2022-06-02

Healthy Volunteers

No

Interventions

OTHER

ICG dye

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

Locations (1)

University Health Network

Toronto, Ontario, Canada