An interventional study of Sinonasal Benign or Malignant Tumor Resection and Skull Base Surgery (Assessment of Nasoseptal Flap) in Chronic Sinusitis, Tumor of Nasal Sinus and Posterior Epistaxis, sponsored by St. Paul's Sinus Centre. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by St. Paul's Sinus Centre · Not applicable, Interventional, and Other
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.
The investigators aim to evaluate the effectiveness and feasibility of using a fluorescent dye, Indocyanine Green (ICG), in endoscopic sinus, skullbase, sinus tumor resection, or posterior epistaxis surgery.
Adults 19 years or older, seen in the Principal Investigator and Sub investigator's offices presenting with either CRS, benign or malignant sinonasal, skull base tumors, or posterior epistaxis will be identified by the Principal Investigators and invited to participate in this prospective study. Patients will be recruited into the study in a consecutive manner. After providing consent, baseline characteristics will be collected. The investigators aim to recruit 10 patients in each study group respectively given the patients diagnosis.
Sinus tumor resection - Initially margins will be estimated with the naked eye. Then they will be compared to the margins that are fluorescing with the dye.
Skull base tumor resection - The investigators will use a part of the participant's septum for the reconstruction. The investigators will measure the time it takes for the flap to fluoresce and ensure that it is still lighting up at the end of the surgery. This means that it is still receiving a good supply and ensures longevity of the flap.
Sinus Surgery - During the participant's surgery, the investigator will come across important vessels that will be preserved. The investigator will see if the ICG is able to light up those vessels and if it does, then measure the time it takes to light up will be measured.
Posterior epistaxis - If a participant experiences a nose bleed that requires going into the operating room, the investigator will use ICG to locate the vessel that needs to be cauterized. The investigators will measure the time it takes for that vessel to light up.
The investigator will see the participants back on their day of surgery. During surgery, Indocyanine Green (ICG) will be injected through their intravenous line. The investigator will start with the smallest dose and increase to a dose that allows us to see the structures of interest such as vessels or tumor margins. The time it takes for a vessel or margins of a tumor to light up will be measured. Intra-operative data specific to each type of surgery being performed will be collected.
Dose-Escalation Protocol Intravenous injection
Intralesional injection
Descriptive statistics (count, absolute frequency, and 95% confidence interval) will be used to analyze the baseline characteristic data.
24 studies on the registry are indexed under Paranasal Sinus Neoplasms; 6 are open to participants now.
This study's planned enrollment of 40 is close to the median of 37 across 20 interventional studies indexed under Paranasal Sinus Neoplasms.
Browse Paranasal Sinus Neoplasms studies →St. Paul's Sinus Centre is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.
Procedure: Sinonasal Benign or Malignant Tumor Resection
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)
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
Those who have severe nose bleeds and requires going into the operating room for management.
Procedure: Posterior Epistaxis Management (SPA Ligation)
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.
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.
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.
During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.
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.
Time frame: Intra-operatively
Cumulative amount of ICG administrated
The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
Time frame: Intra-operatively
Maximum Dose of ICG administrated
The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
Time frame: 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.
Time frame: Intra-operatively
Adverse Rections to ICG
Any adverse events to ICG that are experienced will be collected.
Time frame: Intra-operatively
No study locations are listed for this record.
Start is estimated for Jan 2023; primary completion for Sep 2023, 8 months later.
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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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