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

NCT04374448 | Unknown

• 1 other identifier: NIRF ICG Protocol
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Indocyanine Green; Endoscopic Sinus Surgery; Skullbase Surgery; Sinonasal tumors

Outcome Measures

Primary Outcomes (4)

• Timing of ICG administration to fluorescence of distinct structures

  During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.

  Intra-operatively

• Cumulative amount of ICG administrated

  The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.

  Intra-operatively

• Maximum Dose of ICG administrated

  The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.

  Intra-operatively

• Images of surgeon estimated origin & margin, ICG estimated origin & margin

  Images of the structure of interests origins and margins will be captured. Images estimated by the surgeon and ICG will be collected.

  Intra-operatively

Secondary Outcomes (1)

• Adverse Rections to ICG

  Intra-operatively

Study Arms (4)

Sinus Tumor Resection

OTHER

Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.

Procedure: Sinonasal Benign or Malignant Tumor Resection

Skull Base Surgery

OTHER

Those who are receiving Endoscopic Skull Base Surgery (ESBS) for minimally-invasive access for removal of skull base tumors, most commonly for ones of pituitary origin.

Procedure: Skull Base Surgery (Assessment of Nasoseptal Flap)

Endoscopic Sinus Surgery

OTHER

Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses.

Procedure: Endoscopic Sinus Surgery

Epistaxis Management

OTHER

Those who have severe nose bleeds and requires going into the operating room for management.

Procedure: Posterior Epistaxis Management (SPA Ligation)

Interventions

Sinonasal Benign or Malignant Tumor Resection PROCEDURE

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.

Sinus Tumor Resection

Skull Base Surgery (Assessment of Nasoseptal Flap) PROCEDURE

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.

Skull Base Surgery

Endoscopic Sinus Surgery PROCEDURE

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.

Endoscopic Sinus Surgery

Posterior Epistaxis Management (SPA Ligation) PROCEDURE

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

Epistaxis Management

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing skull base surgery with nasoseptal flap reconstruction.
• All patients undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.
• All patients undergoing endoscopic sinus surgery for chronic rhinosinusitis (CRS) with or without polyposis.
• All patients undergoing surgical intervention for posterior epistaxis.

You may not qualify if:

• Patients less than 18 years of age
• Patients whom are currently pregnant
• Patients with allergies to sodium iodide or shellfish
• Patients with previous anaphylactic reaction to ICG

Sponsors & Collaborators

• St. Paul's Sinus Centre: lead

MeSH Terms

Conditions

Paranasal Sinus Neoplasms; Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Nose Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Prospective Case-Series and Feasibility Study

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 5, 2020
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11