Upfront Ultrasound for Preoperative Localization in Primary Hyperparathyroidism
- Conditions
- Primary Hyperparathyroidism
- Registration Number
- NCT07068867
- Lead Sponsor
- Odense University Hospital
- Brief Summary
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
- Detailed Description
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.
The study aims to benefit both patients and society as it intends to decrease patient exposure to radiation, reduce costs, and reduce the time patients have to take off from work for the purpose of preoperative imaging. One less hospital visit will also reduce the pollution caused by an extra day of transportation to and from the hospital.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.
- Other causes of hypercalcemia
- Persistent or recurrent hyperparathyroidism.
- Previous surgery to the thyroid or the parathyroid glands.
- Inability to read/speak Danish
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of the sequential imaging regimen (upfront ultrasound) 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.
- Secondary Outcome Measures
Name Time Method Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 2" No residual disease 6 months after surgery The primary endpoint re-calculated with a theoretical cut-off at "diagnostic confidence score=2" as the criteria that leads to surgery without additional imaging.
Patients that didn't need supplementary imaging 6 months post-surgery Fractions of patients that didn't need supplementary imaging.
Surgery duration Immediately after surgery Discrepancy between expected and actual duration of surgery.
Unnecessarily explored quadrants 6 months post-surgery Number of unnecessarily explored quadrants
Complication rate From surgery until one year after surgery Complication rate in terms of recurrent nerve paralysis, post-operative hemorrhage, or permanent hypoparathyroidism
Cost Through study completion, from baseline to 6 months post-surgery Cost of ultrasound, parathyroid scintigraphy and parathyroid choline PET/CT
Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 1" No residual disease 6 months after surgery The primary endpoint re-calculated with a theoretical cut-off at "diagnostic confidence score=1" as the criteria that leads to surgery without additional imaging.
Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen 6 months after surgery Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen
Unnecessary supplementary imaging 6 months post-surgery Fraction of unnecessary supplementary imaging
Cure rate No residual disease 6 months after surgery No hyperparathyroid hypercalcemia
Confounding Baseline to 6 months post-surgery Is the sensitivity influenced by differences in patient age, sex, BMI, adenoma weight, adenoma depth, adenoma diameter, multiple gland disease, preoperative ionized calcium and preoperative PTH?
Trial Locations
- Locations (1)
Odense University Hospital
🇩🇰Odense, Denmark
Odense University Hospital🇩🇰Odense, Denmark