2024-516255-41-00招募中3 期
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (HYPOCAAVI)
Centre Hospitalier Regional Et Universitaire De Brest1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2024年7月31日最近更新:
相关药物
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
- Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
研究概览
简要总结
Compare the incidence of albumin-corrected hypocalcaemia (blood calcium less than 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the group using indocyanine green and the group not using indocyanine green.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients requiring total thyroidectomy
- •Signed consent
- •Patient covered by a social security scheme
排除标准
- •Patients under 18 years of age
- •Protected adult or person incapable of giving consent to the study
- •Pregnant and breast-feeding women
- •Total thyroidectomy (removal of the remaining thyroid lobe in a patient who has already had a hemi thyroidectomy)
- •Previous thyroid or parathyroid surgery
- •Refusal to participate
- •Known allergic reaction to indocyanine green (ICG)
- •Women of childbearing age not using an adequate method of contraception
结局指标
主要结局
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
次要结局
- Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6
- Modification (yes/no) of the surgical procedure by improving detection of the parathyroids or their vascularisation during thyroidectomy with the use of indocyanine green angiography
- Intraoperative parathyroid vitality score when using indocyanine green angiography
- Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)
- Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcaemia in the 48 postoperative hours
- Occurrence of an adverse reaction linked to the injection of indocyanine green
研究者
Dr Jean-Christophe LECLERE
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (1)
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