Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
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
Primary outcome measure(s)
- 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. — Day 2
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CHRU de Brest | Brest | France | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04785443 on ClinicalTrials.gov ↗ ← All trials in France