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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

* 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient having to undergo a total thyroidectomy - Signed consent - Patient beneficiary of a social security regimen Who Should NOT Join This Trial: - Minor patient under 18 years old - Major patient protected by law or unable to give willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient having to undergo a total thyroidectomy * Signed consent * Patient beneficiary of a social security regimen 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

Treatments Being Tested

DRUG

ICG

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.

PROCEDURE

Control 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.

Locations (1)

CHRU de Brest
Brest, France