An observational study in Primary Hyperparathyroidism, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Odense University Hospital · Observational
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
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's enrollment of 99 is below the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
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Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sensitivity of the sequential imaging regimen (upfront ultrasound)
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.
Time frame: No residual disease 6 months after surgery
Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 2"
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.
Time frame: No residual disease 6 months after surgery
Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 1"
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.
Time frame: No residual disease 6 months after surgery
Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen
Per gland sensitivity, specificity, positive and negative predictive value of the sequential imaging regimen
Time frame: 6 months after surgery
Patients that didn't need supplementary imaging
Fractions of patients that didn't need supplementary imaging.
Time frame: 6 months post-surgery
Surgery duration
Discrepancy between expected and actual duration of surgery.
Time frame: Immediately after surgery
Unnecessary supplementary imaging
Fraction of unnecessary supplementary imaging
Time frame: 6 months post-surgery
Unnecessarily explored quadrants
Number of unnecessarily explored quadrants
Time frame: 6 months post-surgery
Complication rate
Complication rate in terms of recurrent nerve paralysis, post-operative hemorrhage, or permanent hypoparathyroidism
Time frame: From surgery until one year after surgery
Cure rate
No hyperparathyroid hypercalcemia
Time frame: No residual disease 6 months after surgery
Cost
Cost of ultrasound, parathyroid scintigraphy and parathyroid choline PET/CT
Time frame: Through study completion, from baseline to 6 months post-surgery
Confounding
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?
Time frame: Baseline to 6 months post-surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Sep 2025, 24 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Primary →