This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.
Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands. Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal. Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
University Health Network
Toronto, Ontario, Canada
Quantification of the fluorescent signal of ICG
Quantification of the fluorescent signal of ICG
Time frame: At time of surgery
Appearance of parathyroid gland
Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)
Time frame: At time of surgery
Duration of surgery
Duration of surgery in minutes
Time frame: From start to end of surgery
Postoperative calcium concentration
Postoperative albumin-corrected calcium concentration in blood
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Postoperative PTH concentration
Postoperative PTH concentration in blood
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative calcium medication
Rate of prescribed postoperative calcium medication
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative vitamin D medication
Rate of prescribed postoperative vitamin D medication
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
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