Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
研究概览
简要总结
This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).
SECONDARY OBJECTIVES:
I. Cost-analysis to determine savings of omission of intraoperative PTH testing.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism
- •Preoperative serum calcium levels >= 10.9 mg/dL
- •Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
- •Patient has no history of prior neck surgery or external radiation to neck for malignant conditions
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Patient has recurrent hyperparathyroidism
- •4D CT positive for multiple gland disease
- •Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease)
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or nursing female subjects; may be determined in the preoperative evaluation
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
结局指标
主要结局
Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
时间窗: At 2 weeks
Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.
次要结局
- Post-operative cost analysis(At 2 weeks)