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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ICG

    Drug

    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.

  • Control group

    Procedure/Surgery

    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.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: ICG groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 2

Secondary outcomes

1

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

Time frame
Day 8, Month 1 and Month 6
2

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.

Time frame
Day 0
3

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.

Time frame
Day 0
4

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).

Time frame
Day 1 and Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.