Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02381925|
Recruitment Status : Withdrawn (The study never opened due to funding issues)
First Posted : March 6, 2015
Last Update Posted : September 21, 2015
The study aims are:
- To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
- 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).
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
- diagnostic performance of imaging [ Time Frame: 6 months ]
- ability to perform focused parathyroidectomy [ Time Frame: 6 months ]
- rates of persistent hyperparathyroidism after parathyroidectomy [ Time Frame: 6 months ]
- parathyroidectomy surgical complications [ Time Frame: 6 months ]