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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05328076
Acronym
ANGIO_PARA
Enrollment
22
Registered
2022-04-14
Start date
2022-05-02
Completion date
2023-01-19
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoparathyroidism, Thyroid, Thyroid Cancer, Vascularization

Keywords

Parathyroid, Thyroid surgery, Indocyanine green angiography

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.

Interventions

DRUGIndocyanine green

Indocyanine green is used to perform intraoperative angiography.

DEVICESPY Portable Handheld Imaging (SPY-PHI)

The device is used to perform intraoperative angiography.

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vascularization scoreIntraoperativelyA 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026