Minimally Invasive Radioguided Parathyroidectomy

Completed

• Conditions: Primary Hyperparathyroidism
• Interventions: Procedure: Minimally invasive radioguided parathyroidectomy

• Registration Number: NCT01530919
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study Start: 1998-09
• Primary Completion: 2009-12
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-10
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

• All patients with biochemical evidence of primary hyperparathyroidism

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parathyroid surgery	Minimally invasive radioguided parathyroidectomy	Database of patients who have undergone minimally invasive radioguided parathyroidectomy

Primary Outcome Measures

Name	Time	Method
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas.	2-3days

Secondary Outcome Measures

Name	Time	Method
Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis	day of surgery (1 day)
The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism	2-3 days

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States