NCT05328076

Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Thyroid
• Thyroid Cancer
• Hypoparathyroidism
• Vascularization

Interventions

Type	Name	Description
DRUG	Indocyanine green	Indocyanine green is used to perform intraoperative angiography.
DEVICE	SPY Portable Handheld Imaging (SPY-PHI)	The device is used to perform intraoperative angiography.

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2022-04-14
• Last updated: 2024-07-05

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study
• FDA-regulated device study