RecruitingPhase 2NCT05350540

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

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


Sponsor

University Health Network, Toronto

Enrollment

70 participants

Start Date

Nov 11, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ICG dye for people with surgery site fistula. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERICG 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

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NCT05350540