Contribution of ICG Angiography in the Detection of Parathyroids &

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life. The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands. The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge. The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism. In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04785443
Study type	Interventional
Source	University Hospital, Brest
Contact	Jean-Christophe LECLERE, PhD
Phone	0298223630
Email	jean-christophe.leclere@chu-brest.fr
Status	Recruiting
Phase	Phase 3
Start date	June 22, 2021
Completion date	March 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms