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Recruiting Phase 3

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

NCT04785443 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2021-06-22
Last updated
2026-03-19

Condition(s) studied

Thyroid Diseases

Investigational drug(s) / intervention(s)

ICGControl group

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
CHRU de Brest Brest France Recruiting

Other trials for the same condition

Official registry record

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