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Minimally Invasive Radioguided Parathyroidectomy (MIRP)

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ClinicalTrials.gov Identifier: NCT01530919
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Norton Healthcare
Jewish Hospital and St. Mary's Healthcare
Information provided by (Responsible Party):
Michael B. Flynn, MD, University of Louisville

November 30, 2011
February 10, 2012
May 4, 2017
September 1998
December 2009   (Final data collection date for primary outcome measure)
The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. [ Time Frame: 2-3days ]
To determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. [ Time Frame: 2-3days ]
Complete list of historical versions of study NCT01530919 on ClinicalTrials.gov Archive Site
  • The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism [ Time Frame: 2-3 days ]
  • Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis [ Time Frame: day of surgery (1 day) ]
  • To determine the value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism [ Time Frame: 2-3 days ]
  • To collect abnormal parathyroid tissue at the time of surgery for tissue analysis [ Time Frame: day of surgery (1 day) ]
Not Provided
Not Provided
 
Minimally Invasive Radioguided Parathyroidectomy
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).
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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Small portion of abnormal parathyroid gland that is removed during surgery is frozen and stored for future research.
Non-Probability Sample
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.
Primary Hyperparathyroidism
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.
Parathyroid surgery
Database of patients who have undergone minimally invasive radioguided parathyroidectomy
Intervention: Procedure: Minimally invasive radioguided parathyroidectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
856
1000
April 2017
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with biochemical evidence of primary hyperparathyroidism
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01530919
291.97
No
Not Provided
Not Provided
Michael B. Flynn, MD, University of Louisville
University of Louisville
  • Norton Healthcare
  • Jewish Hospital and St. Mary's Healthcare
Principal Investigator: Michael J Flynn, M.D. University of Louisville
University of Louisville
May 2017