Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Terminated

• Conditions: Vascularization; Thyroid Cancer; Hypoparathyroidism; Thyroid
• Interventions: Drug: Indocyanine green; Device: SPY Portable Handheld Imaging (SPY-PHI)

• Registration Number: NCT05328076
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-05-02
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Able to sign informed consent
• Indication to total thyroidectomy
• No contraindication to indocyanine green administration

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Exclusion Criteria

• Evidence of parathyroid disease
• Allergy to iodinated contrast
• Chronic kidney failure
• Pregnancy or lactation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical group	Indocyanine green	Patients who undergo thyroid surgery and receive indocyanine green angiography
Surgical group	SPY Portable Handheld Imaging (SPY-PHI)	Patients who undergo thyroid surgery and receive indocyanine green angiography

Primary Outcome Measures

Name	Time	Method
Vascularization score	Intraoperatively	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.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy