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

Parathyroid Disease Clinical Trial

Official title:

Relationship of Preoperative PTH and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539486
• Other study ID #: 112684
• Status: Completed
• Start date: January 2010
• Est. completion date: December 2022

Study information

• Verified date: January 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parathyroid Disease
• Parathyroid Diseases

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Retrospective Chart Review