Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
研究概览
简要总结
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.
详细描述
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Adult patients ≥18 years of age
- •Undergoing total thyroidectomy, or completion total thyroidectomy
- •Pre-operative serum adjusted calcium levels within normal ranges
排除标准
- •Patients on pre-operative calcium or vitamin D supplements
- •Patients with pre-operative vitamin D deficiency, defined as serum vitamin D<30nmol/L
- •Patients with untreated primary or secondary hyperparathyroidism
- •Patient with known non-surgical hypoparathyroidism diseases
- •Patients with estimated glomerular filtration rate <30ml/1.73m2/min, on dialysis, or having a history of kidney transplant
研究组 & 干预措施
Conventional total thyroidectomy
Total thyroidectomy without PTeye™
Total thyroidectomy with the PTeye™ parathyroid detection system
PTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery.
干预措施: PTeye™ parathyroid detection system (Device)
结局指标
主要结局
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
时间窗: 6 months
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
次要结局
- Rate of inadvertent parathyroidectomy (in %)(within 4 weeks from operation)
- Rate of parathyroid auto-transplantation (in %)(within operation)
- Day 0 PTH(Post-operative Day 0)
- Day 1 Post-operative serum parathyroid hormone levels (pmol/L)(Post-operative Day 1)
- 3-month Post-operative serum parathyroid hormone levels (pmol/L)(Post-operative 3 months)
- 6-month Post-operative serum parathyroid hormone levels (pmol/L)(Post-operative 6 months)
研究者
Man Him Matrix Fung
Clinical Assistant Professor
The University of Hong Kong