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Completed

NCT Number: NCT01530919

Minimally Invasive Radioguided Parathyroidectomy

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).

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with biochemical evidence of primary hyperparathyroidism

Treatment and study plan

Minimally invasive radioguided parathyroidectomy

Procedure

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.

Primary outcomes

  1. The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas.

    Time frame: 2-3days

Secondary outcomes

  1. The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism

    Time frame: 2-3 days

  2. Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis

    Time frame: day of surgery (1 day)

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Jewish Hospital and St. Mary's Healthcare
  • Norton Healthcare

Registry information

Acronym: MIRP

Important dates

Study start
1998
Primary completion
2009
Study completion
2017
First posted
Feb 10, 2012
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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