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Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02381925
Enrollment
0
Registered
2015-03-06
Start date
Unknown
Completion date
2016-12-31
Last updated
2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid Adenoma

Keywords

CT, Scintigraphy, Ultrasound

Brief summary

The study aims are: 1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism. 2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery. Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS). There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care. The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).

Interventions

None listed

Sponsors

University of California, Los Angeles
CollaboratorOTHER
University of Arkansas
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016

Exclusion criteria

* age less than 18 years * parathyroid carcinoma * secondary or tertiary hyperparathyroidism

Design outcomes

Primary

MeasureTime frame
diagnostic performance of imaging6 months

Secondary

MeasureTime frame
ability to perform focused parathyroidectomy6 months
rates of persistent hyperparathyroidism after parathyroidectomy6 months
parathyroidectomy surgical complications6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026