Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Parathyroid Gland Fluorescence Intensity
研究概览
简要总结
This single-center, prospective, three-phase observational cohort quantifies the relationship between indocyanine green (ICG) fluorescence and early parathyroid function. Adult patients scheduled for unilateral thyroid lobectomy with autotransplantation of the ipsilateral inferior parathyroid gland are enrolled. After intravenous ICG 25 µg/kg, peak fluorescence of the superior parathyroid gland and the common carotid artery (CCA) is recorded at 60-120 seconds to calculate the ratio R = PTG/CCA. Serum parathyroid hormone (PTH) is measured 30 minutes post-operatively. A derivation cohort (~120 patients) generates R-based thresholds for in-situ preservation versus autotransplantation, which are prospectively validated in an independent cohort (60 patients) together with decision-curve analysis of clinical net benefit.
详细描述
Post-thyroidectomy hypocalcemia, reported in 5-30 % of cases, is largely attributable to inaccurate assessment of parathyroid perfusion. Conventional intra-operative judgment-based on gland color, capillary bleeding and pulsation-is subjective and non-quantitative. Near-infrared fluorescence imaging with indocyanine green (ICG) allows real-time visualization of tissue perfusion, yet no widely accepted quantitative threshold exists to guide in-situ preservation versus autotransplantation of parathyroid glands.
The PT-ICG study addresses this gap through:
Target population: Patients undergoing unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland, isolating evaluation to the superior gland.
Pilot phase (n=30): Optimization confirmed an ICG dose of 25 µg/kg and a 60-120 s acquisition window, with the common carotid artery (CCA) providing a stable reference; well-perfused glands exhibited R values ~0.8-3.0.
Derivation phase (n≈120): The relationship between R and 30-min postoperative PTH is modeled; ROC analysis and the Youden index yield R_low and R_high thresholds, internally validated with bootstrap resampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral thyroid lobectomy plus central (VI-level) lymph-node dissection.
- •Intra-operative findings consistent with:
- •Complete identification and in-situ preservation of the ipsilateral superior parathyroid gland;
- •Complete identification and autotransplantation of the ipsilateral inferior parathyroid gland.
- •Serum 25-hydroxy-vitamin D ≥ 30 ng/mL at baseline; patients below this level may be enrolled after standardized vitamin-D and calcium supplementation with re-test confirming ≥ 30 ng/mL.
- •Surgery and all postoperative follow-up performed at the study center.
- •Able and willing to provide written informed consent.
排除标准
- •Prior surgery on the thyroid or parathyroid glands.
- •Severe hepatic or renal impairment, or other serious metabolic bone disease.
- •Pregnancy or lactation.
- •Known hypersensitivity to indocyanine green or iodine-containing compounds.
- •Inability or unwillingness to comply with postoperative visits and blood testing.
结局指标
主要结局
Parathyroid Gland Fluorescence Intensity
时间窗: Intra-operative (60 - 120 s post-ICG)
Peak fluorescence intensity of the ipsilateral superior parathyroid gland, captured 60 - 120 seconds after a single intravenous bolus of indocyanine green (25 µg/kg).
Common Carotid Artery (CCA) Fluorescence Intensity
时间窗: Intra-operative (60 - 120 s post-ICG)
Peak fluorescence intensity of the ipsilateral common carotid artery recorded in the same 60 - 120 second window; serves as the reference signal for perfusion ratio calculations.
Parathyroid Hormone (PTH) at 30 Minutes post-surgery
时间窗: 30 minutes after surgery
PTH concentration (pg/mL) measured by chemiluminescent assay 30 minutes after skin closure, reflecting immediate functional status of the preserved superior parathyroid gland.
次要结局
- Administered ICG Dose(Intra-operative (time of injection))
- PTH at 6 Hours(6 hours post-surgery)
- PTH at 2 Weeks(2 weeks post-surgery)
研究者
Bo Wang,MD
Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University