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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient having to undergo a total thyroidectomy
Signed consent
Patient beneficiary of a social security regimen
Disqualifiers
Minor patient under 18 years old
Major patient protected by law or unable to give informed consent
Pregnant or breastfeeding woman
Thyroidectomy totalization
Trial design
Parallel
Treatments tested in this trial
ICG
DrugDuring 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.
Control group
Procedure/SurgeryDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group.
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
Secondary outcomes
Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.
Occurrence (yes/no) of albumin-corrected (\<2mmol/L) postoperative hypocalcemia at D8, M1 and M6
Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.
Modification (yes/no) of the surgical procedure by improving the detection of parathyroids or their vascularization during thyroidectomy with the use of indocyanine green angiography.
To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.
Intraoperative parathyroid vitality score (0=devascularized parathyroid gland to 2 = vascularized thyroid gland) when using indocyanine green angiography.
To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.
Occurrence (yes/no) of hypo parathormone at D1 and D2 postoperatively (\<10ng/L).
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