Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Parathyroid Adenoma Clinical Trial

Official title:

Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02381925
• Other study ID #: Pro00061739
• Status: Withdrawn
• Phase: N/A
• First received: March 3, 2015
• Last updated: September 17, 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Adenoma

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	University of Arkansas, University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic performance of imaging		6 months	No
Secondary	ability to perform focused parathyroidectomy		6 months	No
Secondary	rates of persistent hyperparathyroidism after parathyroidectomy		6 months	No
Secondary	parathyroidectomy surgical complications		6 months	No