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

Официальное название

Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

Обзор

* 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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Процедура 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.

Первичные конечные точки

• 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. [Срок оценки: Day 2]

Вторичные конечные точки (6)

• Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy. [Срок оценки: Day 8, Month 1 and Month 6]
• Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands. [Срок оценки: Day 0]
• To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia. [Срок оценки: Day 0]
• To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy. [Срок оценки: Day 1 and Day 2]
• Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group. [Срок оценки: D1 and D2]
• Evaluate the tolerance of indocyanine green. [Срок оценки: Day 1, Day 2, Day 10]

Критерии участия

Критерии включения

• Patient having to undergo a total thyroidectomy
• Signed consent
• Patient beneficiary of a social security regimen

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHRU de Brest — Brest

Идентификаторы

NCT: NCT04785443 · 29BRC20.0208

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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