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

S

San Donato Group (GSD)

Status

Active, not recruiting

Conditions

Vascularization
Thyroid
Thyroid Cancer
Hypoparathyroidism

Treatments

Drug: Indocyanine green
Device: SPY Portable Handheld Imaging (SPY-PHI)

Study type

Observational

Funder types

Other

Identifiers

NCT05328076
ANGIO PARA

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 1 patient group

Surgical group
Description:
Patients who undergo thyroid surgery and receive indocyanine green angiography
Treatment:
Device: SPY Portable Handheld Imaging (SPY-PHI)
Drug: Indocyanine green

Trial contacts and locations

1

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Central trial contact

Riccardo Maggiore, Dr.

Data sourced from clinicaltrials.gov

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