Minimally Invasive Radioguided Parathyroidectomy

NCT01530919 | Completed

• 1 other identifier: 291.97
• Study Type: observational
• Target: 856
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

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

  2-3days

Secondary Outcomes (2)

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

  2-3 days

• Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis

  day of surgery (1 day)

Study Arms (1)

Parathyroid surgery

Database of patients who have undergone minimally invasive radioguided parathyroidectomy

Procedure: Minimally invasive radioguided parathyroidectomy

Interventions

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.

Parathyroid surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients with biochemical evidence of primary hyperparathyroidism

Sponsors & Collaborators

• University of Louisville: lead
• Norton Healthcare: collaborator
• Jewish Hospital and St. Mary's Healthcare: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (12)

• 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.

  PMID: 21679561 RESULT

• 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.

  PMID: 16540904 RESULT

• 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.

  PMID: 25975331 RESULT

• 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.

  PMID: 10898180 RESULT

• 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.

  PMID: 15663056 RESULT

• 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.

  PMID: 16785355 RESULT

• 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.

  PMID: 17071309 RESULT

• 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.

  PMID: 17216827 RESULT

• 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.

  PMID: 17879694 RESULT

• 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.

  PMID: 26031271 RESULT

• 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.

  PMID: 19160424 RESULT

• 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.

  PMID: 19950385 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Small portion of abnormal parathyroid gland that is removed during surgery is frozen and stored for future research.

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Michael J Flynn, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: February 10, 2012
• Study Start: September 1, 1998
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)