Minimally Invasive Radioguided Parathyroidectomy (MIRP)

May 1, 2017 updated by: Michael B. Flynn, MD, University of Louisville
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

856

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults and minors diagnosed with primary hyperparathyroidism that will be having minimally invasive radioguided parathyroidectomy surgery to correct this condition at either Norton Hospital, University of Louisville Hospital or Jewish Hospital.

Description

Inclusion Criteria:

  • All patients with biochemical evidence of primary hyperparathyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parathyroid surgery
Database of patients who have undergone minimally invasive radioguided parathyroidectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas.
Time Frame: 2-3days
2-3days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Norton Healthcare
Jewish Hospital and St. Mary's Healthcare

Investigators

  • Principal Investigator: Michael J Flynn, M.D., University Of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291.97

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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