Minimally Invasive Radioguided Parathyroidectomy

NCT ID: NCT01530919

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

856 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-09-30

Study Completion Date

2017-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Primary Hyperparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parathyroid surgery

Database of patients who have undergone minimally invasive radioguided parathyroidectomy

Minimally invasive radioguided parathyroidectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with biochemical evidence of primary hyperparathyroidism
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norton Healthcare

OTHER

Sponsor Role collaborator

Jewish Hospital and St. Mary's Healthcare

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Michael B. Flynn, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Flynn, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21679561 (View on PubMed)

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. doi: 10.1097/01.mlg.0000195288.06601.18.

Reference Type RESULT
PMID: 16540904 (View on PubMed)

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.

Reference Type RESULT
PMID: 25975331 (View on PubMed)

Flynn MB, Bumpous JM, Schill K, McMasters KM. Minimally invasive radioguided parathyroidectomy. J Am Coll Surg. 2000 Jul;191(1):24-31. doi: 10.1016/s1072-7515(00)00297-0.

Reference Type RESULT
PMID: 10898180 (View on PubMed)

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.

Reference Type RESULT
PMID: 15663056 (View on PubMed)

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. doi: 10.1001/archsurg.141.6.552.

Reference Type RESULT
PMID: 16785355 (View on PubMed)

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. doi: 10.1016/j.otohns.2006.05.026.

Reference Type RESULT
PMID: 17071309 (View on PubMed)

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.

Reference Type RESULT
PMID: 17216827 (View on PubMed)

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.

Reference Type RESULT
PMID: 17879694 (View on PubMed)

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.

Reference Type RESULT
PMID: 26031271 (View on PubMed)

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.

Reference Type RESULT
PMID: 19160424 (View on PubMed)

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.

Reference Type RESULT
PMID: 19950385 (View on PubMed)

Other Identifiers

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291.97

Identifier Type: -

Identifier Source: org_study_id

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