Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography (ANGIO_PARA)

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    66
  • sponsor
    IRCCS San Raffaele
Updated on 12 May 2022
thyroidectomy

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.

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.

Details
Condition Thyroid, Thyroid Cancer, Hypoparathyroidism, Vascularization
Treatment Indocyanine Green, SPY Portable Handheld Imaging (SPY-PHI)
Clinical Study IdentifierNCT05328076
SponsorIRCCS San Raffaele
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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