Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
NCT04785443 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242
Last updated 2026-03-19
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.
Conditions
- Thyroid Diseases
Interventions
- 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.
Sponsors & Collaborators
-
University Hospital, Brest
lead OTHER
Principal Investigators
-
Jean-Christophe LECLERE, PhD · CHRU de Brest
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-22
- Primary Completion
- 2026-06-22
- Completion
- 2027-06-22
Countries
- France
Study Locations
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