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

Study Description

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).

Condition or disease	Intervention/treatment
Primary Hyperparathyroidism	Procedure: Minimally invasive radioguided parathyroidectomy

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 Design

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Study Type :	Observational
Actual Enrollment :	856 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Minimally Invasive Radioguided Parathyroidectomy
Study Start Date :	September 1998
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	April 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial isolated hyperparathyroidism Hyperparathyroidism-jaw tumor syndrome

Genetic and Rare Diseases Information Center resources: Primary Hyperparathyroidism

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530919

Locations

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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

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

More Information

Publications of Results:

Quillo AR, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Minimally invasive parathyroid surgery, the Norman 20% rule: is it valid? Am Surg. 2011 Apr;77(4):484-7.

Grady JA, Bumpous JM, Fleming MM, Flynn MB, Turbiner E, Lentsch EJ, Ziegler CH. Advantages of a targeted approach in minimally invasive radioguided parathyroidectomy surgery for primary hyperparathyroidism. Laryngoscope. 2006 Mar;116(3):431-5.

Flynn MB, Quayyum M, Goldstein RE, Bumpous JM. Outpatient parathyroid surgery: ten-year experience: is it safe? Am Surg. 2015 May;81(5):472-7.

Flynn MB, Bumpous JM, Schill K, McMasters KM. Minimally invasive radioguided parathyroidectomy. J Am Coll Surg. 2000 Jul;191(1):24-31.

Hutchinson JR, Yandell DW, Bumpous JM, Fleming MM, Flynn MB. Three-year financial analysis of minimally invasive radio-guided parathyroidectomy. Am Surg. 2004 Dec;70(12):1112-5.

Goldstein RE, Carter WM 2nd, Fleming M, Bumpous J, Lentsch E, Rice M, Flynn M. Unilateral cervical surgical exploration aided by intraoperative parathyroid hormone monitoring in patients with primary hyperparathyroidism and equivocal sestamibi scan results. Arch Surg. 2006 Jun;141(6):552-7; discussion 557-9.

Kartha SS, Chacko CE, Bumpous JM, Fleming M, Lentsch EJ, Flynn MB. Toxic metabolic encephalopathy after parathyroidectomy with methylene blue localization. Otolaryngol Head Neck Surg. 2006 Nov;135(5):765-8.

Conn CA, Clark J, Bumpous J, Goldstein R, Fleming M, Flynn MB. Hypocalcemia after neck exploration for untreated primary hyperparathyroidism. Am Surg. 2006 Dec;72(12):1234-7.

Han N, Bumpous JM, Goldstein RE, Fleming MM, Flynn MB. Intra-operative parathyroid identification using methylene blue in parathyroid surgery. Am Surg. 2007 Aug;73(8):820-3.

Stephen ET, Quillo AR, Lewis KE, Harden FL, Bumpous JM, Flynn MB, Callender GG. Operative failure rate and documentation of family history in young patients undergoing focused parathyroidectomy for primary hyperparathyroidism. Am Surg. 2015 Jun;81(6):585-90.

Bumpous JM, Goldstein RL, Flynn MB. Surgical and calcium outcomes in 427 patients treated prospectively in an image-guided and intraoperative PTH (IOPTH) supplemented protocol for primary hyperparathyroidism: outcomes and opportunities. Laryngoscope. 2009 Feb;119(2):300-6. doi: 10.1002/lary.20049.

Young VN, Osborne KM, Fleming MM, Flynn MB, Goldstein RE, Bumpous JM. Parathyroidectomy in the elderly population: does age really matter? Laryngoscope. 2010 Feb;120(2):247-52. doi: 10.1002/lary.20706.

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Responsible Party:	Michael B. Flynn, MD, Professor, University of Louisville
ClinicalTrials.gov Identifier:	NCT01530919
Other Study ID Numbers:	291.97
First Posted:	February 10, 2012 Key Record Dates
Last Update Posted:	May 4, 2017
Last Verified:	May 2017

Additional relevant MeSH terms:

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Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases Endocrine System Diseases

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