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

Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for 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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism; Parathyroid Gland Adenoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Parathyroidectomy

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (parathyroidectomy); Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Parathyroidectomy; Undergo parathyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative cost analysis	cost analysis will be based on operative time and omission of intraoperative PTH levels.	At 2 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Moshim Kukar, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma
• Other Study ID Numbers: I 274915 (Other Identifier: Roswell Park Cancer Institute); NCI-2016-01974 (Registry Identifier: CTRP (Clinical Trial Reporting Program))