Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

Last updated: October 23, 2023
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

3

Condition

Hypoparathyroidism

Treatment

ICG

Control group

Clinical Study ID

NCT04785443
29BRC20.0208
  • Ages > 18
  • All Genders

Study Summary

  • Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.

  • Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.

  • The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.

  • This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient having to undergo a total thyroidectomy
  • Signed consent
  • Patient beneficiary of a social security regimen

Exclusion

Exclusion Criteria:

  • Minor patient under 18 years old
  • Major patient protected by law or unable to give informed consent
  • Pregnant or breastfeeding woman
  • Thyroidectomy totalization
  • History of thyroid or parathyroid surgery
  • Participation refusal
  • Known allergy to ICG
  • Woman of child-bearing age not using adequate method of contraception

Study Design

Total Participants: 242
Treatment Group(s): 2
Primary Treatment: ICG
Phase: 3
Study Start date:
June 22, 2021
Estimated Completion Date:
March 31, 2025

Study Description

Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life.

The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands.

The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge.

The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism.

In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates.

Connect with a study center

  • CHRU de Brest

    Brest, 29609
    France

    Active - Recruiting

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