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Minimally Invasive Radioguided Parathyroidectomy (MIRP)

This study has been completed.
Sponsor:
Collaborators:
Norton Healthcare
Jewish Hospital and St. Mary's Healthcare
Information provided by (Responsible Party):
Michael B. Flynn, MD, University of Louisville
ClinicalTrials.gov Identifier:
NCT01530919
First received: November 30, 2011
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
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).

Condition Intervention
Primary Hyperparathyroidism Procedure: Minimally invasive radioguided parathyroidectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Minimally Invasive Radioguided Parathyroidectomy

Resource links provided by NLM:


Further study details as provided by Michael B. Flynn, MD, University of Louisville:

Primary Outcome Measures:
  • The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. [ Time Frame: 2-3days ]

Secondary Outcome Measures:
  • 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) ]

Biospecimen Retention:   Samples With DNA
Small portion of abnormal parathyroid gland that is removed during surgery is frozen and stored for future research.

Enrollment: 856
Study Start Date: September 1998
Study Completion Date: April 2017
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • All patients with biochemical evidence of primary hyperparathyroidism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530919

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Norton Healthcare
Jewish Hospital and St. Mary's Healthcare
Investigators
Principal Investigator: Michael J Flynn, M.D. University of Louisville
  More Information

Publications:

Responsible Party: Michael B. Flynn, MD, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01530919     History of Changes
Other Study ID Numbers: 291.97
Study First Received: November 30, 2011
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 21, 2017