NCT01530919

Minimally Invasive Radioguided Parathyroidectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 856 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).

Detailed description

The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.

Conditions

• Primary Hyperparathyroidism

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive radioguided parathyroidectomy	After the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified.

Timeline

• Start date: 1998-09-01
• Primary completion: 2009-12-01
• Completion: 2017-04-01
• First posted: 2012-02-10
• Last updated: 2017-05-04

Locations

1 site across 1 country: United States