- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539486
Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
September 14, 2023 updated by: University of Arkansas
Relationship of Preoperative PTH and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
An estimated 200 patient charts will be reviewed.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Retrospective Chart Review
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deanne King, MD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
February 21, 2012
First Submitted That Met QC Criteria
February 24, 2012
First Posted (Estimated)
February 27, 2012
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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