The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Images of surgeon estimated origin & margin, ICG estimated origin & margin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Images of surgeon estimated origin & margin, ICG estimated origin & margin
时间窗: Intra-operatively
Images of the structure of interests origins and margins will be captured. Images estimated by the surgeon and ICG will be collected.
Timing of ICG administration to fluorescence of distinct structures
时间窗: Intra-operatively
During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.
Maximum Dose of ICG administrated
时间窗: Intra-operatively
The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
Cumulative amount of ICG administrated
时间窗: Intra-operatively
The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
次要结局
- Adverse Rections to ICG(Intra-operatively)
研究者
Dr. Andrew Thamboo, MD
Assistant Clinical Professor
St. Paul's Sinus Centre