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

Regional University Hospital Center (CHRU)

Status and phase: Enrolling; Phase 3

Conditions: Thyroid Diseases

Treatments: Procedure: Control group; Drug: ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT04785443

29BRC20.0208

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups

ICG group

Experimental group

Description:

Patient receiving 2 or 3 intraoperative injections of indocyanine green.

Treatment:

Drug: ICG

Control group

Other group

Description:

Patient benefiting from the traditional surgical act

Treatment:

Procedure: Control group