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| Name | Class |
|---|---|
| Norton Healthcare | OTHER |
| Jewish Hospital and St. Mary's Healthcare | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parathyroid surgery | Database of patients who have undergone minimally invasive radioguided parathyroidectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. | 2-3days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Flynn, M.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21679561 | Result | 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. | |
| 16540904 | 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. |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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Small portion of abnormal parathyroid gland that is removed during surgery is frozen and stored for future research.
| 25975331 | 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. |
| 10898180 | 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. |
| 15663056 | 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. |
| 16785355 | 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. |
| 17071309 | 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. |
| 17216827 | 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. |
| 17879694 | 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. |
| 26031271 | 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. |
| 19160424 | 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. |
| 19950385 | 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. |