Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Study Overview
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Brief Summary
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Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy. The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism. It is planned to enroll 66 patients.

Detailed Description
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Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia. Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands. The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal. In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Official Title
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Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography

Conditions
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Thyroid, Thyroid Cancer, Hypoparathyroidism, Vascularization

Intervention / Treatment
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* Drug: Indocyanine green
* Device: SPY Portable Handheld Imaging (SPY-PHI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to sign informed consent Indication to total thyroidectomy No contraindication to indocyanine green administration Exclusion Criteria: Evidence of parathyroid disease Allergy to iodinated contrast Chronic kidney failure Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical group<br>Patients who undergo thyroid surgery and receive indocyanine green angiography | Drug: Indocyanine green<br>* Indocyanine green is used to perform intraoperative angiography.<br>Device: SPY Portable Handheld Imaging (SPY-PHI)<br>* The device is used to perform intraoperative angiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascularization score | A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism. The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome. | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroid, Thyroid surgery, Indocyanine green angiography