This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.
PRIMARY OBJECTIVES: I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing). SECONDARY OBJECTIVES: I. Cost-analysis to determine savings of omission of intraoperative PTH testing. OUTLINE: Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. After completion of study, patients are followed up at 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
6
Correlative studies
Undergo parathyroidectomy
Roswell Park Cancer Institute
Buffalo, New York, United States
Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.
Time frame: At 2 weeks
Post-operative cost analysis
cost analysis will be based on operative time and omission of intraoperative PTH levels.
Time frame: At 2 weeks
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