NCT03011736

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parathyroid Gland Adenoma
• Primary Hyperparathyroidism

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Parathyroidectomy	Undergo parathyroidectomy

Timeline

• Start date: 2016-05-12
• Primary completion: 2018-07-12
• Completion: 2018-12-24
• First posted: 2017-01-05
• Last updated: 2021-08-12

Locations

1 site across 1 country: United States