Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Simple blind (only participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having to undergo a total thyroidectomy
- •Signed consent
- •Patient beneficiary of a social security regimen
排除标准
- •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
研究组 & 干预措施
ICG group
Patient receiving 2 or 3 intraoperative injections of indocyanine green.
干预措施: ICG (Drug)
Control group
Patient benefiting from the traditional surgical act
干预措施: Control group (Procedure)
结局指标
主要结局
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.
时间窗: Day 2
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
次要结局
- Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.(Day 8, Month 1 and Month 6)
- To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.(Day 1 and Day 2)
- Evaluate the tolerance of indocyanine green.(Day 1, Day 2, Day 10)
- To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.(Day 0)
- Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.(D1 and D2)
- Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.(Day 0)