RecruitingPhase 3NCT04785443

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

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

Sponsor

University Hospital, Brest

Enrollment

242 participants

Start Date

Jun 22, 2021

Study Type

INTERVENTIONAL

Conditions

Thyroid Diseases

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria8

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

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Interventions

DRUGICG

During thyroidectomy surgery, the patient will received 2 or 3 injections of 5 mg as a bolus. The first one during the dissection of the first lobe, then during the dissection of the second lobe and finally if needed, a 3rd injection will be done at the end of the dissection. Patients will then be followed during 6 months.

PROCEDUREControl group

During thyroidectomy surgery, patients are treated according to traditional surgery with detection of parathyroids with the naked eyes. Patients will then be followed during 6 months.