Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism

Not Applicable

Completed

• Conditions: Parathyroid Gland Adenoma; Primary Hyperparathyroidism
• Interventions: Other: Laboratory Biomarker Analysis; Procedure: Parathyroidectomy

• Registration Number: NCT03011736
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-05-12
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2018-07-12
• Study Completion: 2018-12-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (parathyroidectomy)	Laboratory Biomarker Analysis	Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
Supportive Care (parathyroidectomy)	Parathyroidectomy	Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.

Primary Outcome Measures

Name	Time	Method
Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission	At 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative cost analysis	At 2 weeks	cost analysis will be based on operative time and omission of intraoperative PTH levels.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States