Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism
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.
Inclusion Criteria:

 -  Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary
 hyperparathyroidism

 -  Preoperative serum calcium levels >= 10.9 mg/dL

 -  Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately
 high for associated calcium level

 -  Patient has no history of prior neck surgery or external radiation to neck for
 malignant conditions

 -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

 -  Subject or legal representative must understand the investigational nature of this
 study and sign an Independent Ethics Committee/Institutional Review Board approved
 written informed consent form prior to receiving any study related procedure

 Exclusion Criteria:

 -  Patient has recurrent hyperparathyroidism

 -  4D CT positive for multiple gland disease

 -  Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV)
 allergy, claustrophobia, renal disease)

 -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
 infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
 arrhythmia, or psychiatric illness/social situations that would limit compliance with
 study requirements

 -  Pregnant or nursing female subjects; may be determined in the preoperative evaluation

 -  Unwilling or unable to follow protocol requirements

 -  Any condition which in the investigator's opinion deems the subject an unsuitable
 candidate to undergo observational study (may also include preoperative testing
 results including electrocardiography [EKG], chest x-ray, or pulmonary function tests
 that preclude a wide excision in the operating room)