Clinical trial NCT04785443: Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Official title: Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Diseases
Keywords: Hypocalcemia
Hypoparathyroidism
Angiography
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, comparative, randomized, single-blind, controlled trial against the reference method
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: 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.
timeFrame: Day 2
Secondary outcomes:
measure: Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.
timeFrame: Day 8, Month 1 and Month 6
measure: Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.
timeFrame: Day 0
measure: To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.
timeFrame: Day 0
measure: To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.
timeFrame: Day 1 and Day 2
measure: Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.
timeFrame: D1 and D2
measure: Evaluate the tolerance of indocyanine green.
timeFrame: Day 1, Day 2, Day 10
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Jean-Christophe LECLERE, PhD
role: PRINCIPAL_INVESTIGATOR
References: