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Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

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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Recruitment Status : Withdrawn (The study never opened due to funding issues)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
Sponsor:
Collaborators:
University of California, Los Angeles
University of Arkansas
Information provided by (Responsible Party):
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).


Condition or disease
Parathyroid Adenoma

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. diagnostic performance of imaging [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. ability to perform focused parathyroidectomy [ Time Frame: 6 months ]
  2. rates of persistent hyperparathyroidism after parathyroidectomy [ Time Frame: 6 months ]
  3. parathyroidectomy surgical complications [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will include all patients, aged 18 years or older, who underwent parathyroid surgery from July 2009 to July 2016.
Criteria

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
Additional Information:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02381925    
Other Study ID Numbers: Pro00061739
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015
Keywords provided by Duke University:
CT
Scintigraphy
Ultrasound
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms