Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Withdrawn

• Conditions: Parathyroid Adenoma

• Registration Number: NCT02381925
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-21
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic performance of imaging	6 months

Secondary Outcome Measures

Name	Time	Method
parathyroidectomy surgical complications	6 months
ability to perform focused parathyroidectomy	6 months
rates of persistent hyperparathyroidism after parathyroidectomy	6 months