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Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery

NCT04374448 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-14

No results posted yet for this study

Summary

The endoscope is a device placed into the nasal cavity to remove chronic sinus disease or tumor or create access into the skullbase for extensive tumor removal. Indocyanine Green (ICG) is a dye that is injected through an intravenous site and is used to light up vasculature and margins of a tumor during surgery. This helps avoid damage to important vasculature and obtain clear margins during surgery. This study aims to further assess the utility of ICG when operating within the nasal cavity or skullbase.

Conditions

  • Chronic Sinusitis
  • Tumor of Nasal Sinus
  • Posterior Epistaxis
  • Skull Base Neoplasms

Interventions

PROCEDURE

Sinonasal Benign or Malignant Tumor Resection

During sinus tumor resection, margins will initially be estimated with the naked eye. Then the dye, Indocyanine Green (ICG), will be injected through the intravenous line to identify tumor margins and be compared to estimated margins.

PROCEDURE

Skull Base Surgery (Assessment of Nasoseptal Flap)

In this surgery, a piece of individuals septum will be used for the reconstruction. The amount of time for the flap to fluoresce Indocyanine Green (ICG) will be measured. It will be ensured that the it is still lighting up at the end of the surgery, indicating it is still receiving a good supply and ensures longevity of the flap.

PROCEDURE

Endoscopic Sinus Surgery

During the surgery, the timing of Indocyanine Green (ICG) administration to fluorescence of anterior and posterior ethmoidal artery and of the internal carotid artery will be measured.

PROCEDURE

Posterior Epistaxis Management (SPA Ligation)

During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.

Sponsors & Collaborators

  • St. Paul's Sinus Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-09-01
Completion
2024-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374448 on ClinicalTrials.gov