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Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy

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. Identifier: NCT01539486
Recruitment Status : Active, not recruiting
First Posted : February 27, 2012
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The intent for this study is to do a retrospective chart review of all patients who have undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data collected will be recorded under assigned identification numbers that will have no association with medical record or hospital numbers. Identifying characteristics will include age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All information will be obtained from the medical chart. Demographics, location, preoperative PTH levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based on the hospital notes will be obtained from patients' charts and will be transferred to a secure database. It is our hypothesis that there is a linear relationship between immediate preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this study is to better describe this relationship.

Condition or disease
Parathyroid Disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Relationship of Preoperative PTH and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
Study Start Date : January 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Retrospective Chart Review [ Time Frame: Retrospective Chart Review ]
    The information presented in this report will provide a surgical tool for otolaryngologists to improve the efficiency and efficacy in patients with hyperparathyroid disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An estimated 200 patient charts will be reviewed.

Inclusion Criteria:

  • Patients must be between the ages of 18 and 90 years old who have documented primary hyperparathyroidism and have undergone minimally invasive parathyroidectomy.

Exclusion Criteria:

  • Patients who have not had both intraoperative parathyroid hormone (PTH) levels and Gamma counts during their parathyroidectomy
  • Patients who have parathyroidectomies for reasons other than primary hyperparathyroidism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539486

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Brendan Stack, MD University of Arkansas

Responsible Party: University of Arkansas Identifier: NCT01539486     History of Changes
Other Study ID Numbers: 112684
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Parathyroid Diseases
Endocrine System Diseases