Upfront Ultrasound for Preoperative Localization in Primary Hyperparathyroidism

NCT07068867 | Completed

• 2 other identifiers: Acadre project ID: 23/36379A5992
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Hyperparathyroidism

Keywords

Parathyroid Diseases; Ultrasound; Preoperative Procedures; Preoperative Localization; Endocrine System Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary

Outcome Measures

Primary Outcomes (1)

• 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.

  No residual disease 6 months after surgery

Secondary Outcomes (11)

• Primary outcome re-calculated for a theoretical cut-off at "diagnostic confidence score = 2"

  No residual disease 6 months after 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

• Patients that didn't need supplementary imaging

  6 months post-surgery

• Surgery duration

  Immediately after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.

You may qualify if:

• Patients 18 years and older with primary hyperparathyroidism referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.

You may not qualify if:

• Other causes of hypercalcemia
• Persistent or recurrent hyperparathyroidism.
• Previous surgery to the thyroid or the parathyroid glands.
• Inability to read/speak Danish

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Parathyroid Diseases; Endocrine System Diseases; Hyperparathyroidism

Study Officials

• Sanne H Michaelsen, MD

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

• Viveque Egsgaard, MD, PhD

  Odense Universitetshospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2023
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)