Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

NCT ID: NCT02381925

Last Updated: 2015-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Parathyroid Adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Pro00061739

Identifier Type: -

Identifier Source: org_study_id

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