A Protocolled Implementation of Upfront Ultrasound (Sequential Pre-operative Imaging) in Primary Hyperparathyroidism in the Region of Southern Denmark
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Sensitivity of the sequential imaging regimen (upfront ultrasound)
研究概览
简要总结
Primary hyperparathyroidism is caused by overactive parathyroid glands, leading to elevated calcium levels in the blood. The standard preoperative imaging includes both a radiation-based imaging modality and conventional ultrasound. However, ultrasound alone is a faster, safer, and more patient-friendly alternative. This study evaluates an upfront ultrasound approach, where patients undergo ultrasound first, and only those with certain findings proceed directly to surgery without additional imaging. Patients with uncertain findings proceed to additional imaging. The study is designed as a prospective cohort with a non-inferiority analysis, aiming to confirm whether upfront ultrasound can achieve an acceptable diagnostic sensitivity. If successful, this approach could reduce patient burden, minimize radiation exposure, and optimize healthcare resources
详细描述
This study evaluates the implementation of a stepwise approach using upfront ultrasound for localizing pathological parathyroid glands in patients with primary hyperparathyroidism (PHPT).
PHPT is caused by overactive parathyroid glands, leading to excessive amounts of calcium in the blood, which can result in complications such as kidney stones, osteoporosis, cardiovascular disease, and neurological symptoms. The standard preoperative imaging process currently includes both nuclear medicine scans and ultrasound. However, nuclear imaging is time-consuming, exposes patients to radiation, and may not always provide definitive results.
The proposed approach prioritizes ultrasound as the initial localization tool, with additional imaging reserved for cases where ultrasound findings are inconclusive. This method has the potential to reduce unnecessary hospital visits, minimize radiation exposure, and streamline the diagnostic process. The study aims to ensure that this approach maintains high sensitivity for the localization of pathological parathyroid glands, with a target sensitivity of at least 89.5% for correctly identifying diseased parathyroid glands.
Designed as a prospective cohort study, the project will assess patients using ultrasound first, assigning confidence scores (0-3) to determine whether further imaging is necessary. A confidence-score of 3 indicates a high diagnostic confidence. To gain a score of 3, the potential parathyroid adenoma must meet all predefined criteria, i.e. hypoechogenicity, well-defined margins, location at the anatomically expected position, a polar feeding vessel, and a vascular arc. A diagnostic-score of 2 reflects moderate suspicion, where one or two of these key features are missing. A diagnostic-score of 1 suggests low suspicion, typically characterized by a poorly defined structure with no vascular features. Finally, a diagnostic-score of 0 means that no potential adenoma was detected.
Postoperative findings will confirm the accuracy of the preoperative imaging with the histopathological result of the surgically removed specimen(s) combined with biochemical cure at 6 months as the reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.
排除标准
- •Other causes of hypercalcemia
- •Persistent or recurrent hyperparathyroidism.
- •Previous surgery to the thyroid or the parathyroid glands.
- •Inability to read/speak Danish
结局指标
主要结局
Sensitivity of the sequential imaging regimen (upfront ultrasound)
时间窗: No residual disease 6 months after surgery
The primary outcome measure is the sensitivity of the sequential imaging regimen (upfront ultrasound) for localizing one or more pathological parathyroid glands to the correct quadrant of the neck. The reference standard is histopathology combined with biochemical cure.
次要结局
- Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 2"(No residual disease 6 months after surgery)
- Patients that didn't need supplementary imaging(6 months post-surgery)
- Surgery duration(Immediately after surgery)
- Unnecessarily explored quadrants(6 months post-surgery)
- Complication rate(From surgery until one year after surgery)
- Cost(Through study completion, from baseline to 6 months post-surgery)
- Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 1"(No residual disease 6 months after surgery)
- Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen(6 months after surgery)
- Unnecessary supplementary imaging(6 months post-surgery)
- Cure rate(No residual disease 6 months after surgery)
- Confounding(Baseline to 6 months post-surgery)