Actively Recruiting
Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Led by University Hospital, Brest · Updated on 2026-03-19
242
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypoparathyroidism is a common complication following total thyroidectomy surgery, often temporary but sometimes permanent if lasting beyond six months. Permanent hypoparathyroidism requires lifelong replacement therapy and significantly impacts quality of life. This trial evaluates the use of indocyanine green (ICG) angiography during surgery to detect parathyroid glands and potentially reduce postoperative hypoparathyroidism rates. Participants are randomly assigned to one of two groups: the ICG group receiving two or three intraoperative injections of 5 mg ICG during thyroidectomy, and the control group undergoing traditional surgery with visual detection of parathyroids. Both groups are followed for six months after surgery to monitor outcomes. During the study, researchers will assess blood calcium levels to detect hypocalcemia, examine the rate of definitive hypoparathyroidism at various time points up to six months, and evaluate the ability of ICG angiography to detect and preserve parathyroid glands. Safety and tolerance of ICG are also monitored. The primary outcome is the frequency of hypocalcemia two days after surgery, with several secondary outcomes tracked over time.
CONDITIONS
Brief Title
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient having to undergo a total thyroidectomy
- Signed consent
- Patient beneficiary of a social security regimen
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo total thyroidectomy surgery. Those in the experimental group receive 2 or 3 intraoperative injections of indocyanine green, while those in the control group undergo traditional surgery with visual identification of parathyroids.
1 surgery visit (in-person)
Duration - 6 months
Participants are followed for 6 months after surgery to monitor for hypoparathyroidism and assess recovery.
Visits on Day 0, Day 1, Day 2, Day 8, Day 10, Month 1, and Month 6
Trial Site Locations
Total: 1 location
1
CHRU de Brest
Brest, France, 29609
Actively Recruiting
Research Team
J
Jean-Christophe LECLERE, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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