Unilateral Versus Bilateral Neck Exploration for Primary Hyperparathyroidism : A Prospective Randomized Controlled Trial

Population-based screenings for primary hyperparathyroidism have failed to systematically use intact parathyroid hormone (PTH) values for diagnosis, to explore prevalence and diagnostic criteria of normocalcemic hyperparathyroidism, and to attempt surgical verification of the disorder. A total of 5202 women (ages, 55 to 75 years) attending a population-based mammography screening were investigated for primary hyperparathyroidism. In women lacking a family history of hypercalcemia, significant renal impairment, or low urinary calcium excretion hyperparathyroidism was diagnosed on the basis of predetermined criteria encompassing lower intact serum PTH levels in hypercalcemia (serum PTH 25 ng/L or greater; reference range, 12 to 55 ng/L) than in two intervals of normocalcemia (serum PTH 35 or greater, greater than 55 ng/L). Prevalence of hyperparathyroidism was 2.1% (n = 109). At diagnosis total serum calcium and serum PTH levels were 2.32 to 3.19 mmol/L and 34 to 300 ng/L, respectively, and 66% of the women exhibited normocalcemia. Repeated examination showed persistent normocalcemia in 30 patients, and all but two of them had normal ionized plasma calcium levels. Significantly higher serum calcium, serum PTH, and urine calcium--but not serum creatinine--levels were found in patients with hyperparathyroidism compared with matched control subjects from the screened population. Within an ongoing stratified treatment program, 59 of 60 patients who underwent operation exhibited pathologic parathyroid tissue (mean weight, 591 mg). Substantial prevalence of sporadic primary hyperparathyroidism is demonstrated in a risk group. Although criteria for hyperparathyroidism recognition included patients with truly mild biochemical derangement, operative findings suggested underdiagnosis of the disorder.

To compare the first 20 patients who underwent minimally invasive radioguided parathyroidectomies (MIRPs) performed at the authors' institution with 20 similar patients who underwent a more conventional surgical approach for primary hyperparathyroidism. The technique of parathyroidectomy has traditionally involved a bilateral exploration of the neck with the intent of visualizing four parathyroid glands and resecting enlarged parathyroid glands. Parathyroid scanning using radioisotopes has evolved and now can localize adenomas in 80% to 90% of patients. MIRP combines parathyroid scanning with a hand-held intraoperative detector that guides the surgeon to the adenoma. Forty patients with documented primary hyperparathyroidism who underwent surgery by a single surgeon between January 1998 and May 1999 were included in this study. Twenty of these patients underwent MIRP. The technique involved injecting 20 mCi technetium-99m sestamibi 2 hours before surgery and performing a parathyroid scan. If the scan was considered positive for a single adenoma, patients were taken to the operating room and given the choice of either general anesthesia or intravenous sedation with local anesthesia. Using an incision of 4 cm or less, the dissection down to the adenoma was guided by the Navigator miniature hand-held probe. An additional 20 patients who underwent more conventional bilateral or unilateral neck exploration were chosen to match the MIRP patient population. Both groups included four patients undergoing repeat surgery for persistent or recurrent primary hyperparathyroidism and one patient with multiple endocrine neoplasia type 1 syndrome. Patient demographics, preoperative calcium and parathyroid hormone levels, operative time, total time in the operating room, time in the recovery room, complications, hospital charges for the operating room, and total hospital charges were analyzed. There were no differences in patient demographics, presenting symptoms, or preoperative calcium level between patients undergoing the standard procedure versus MIRP. Operative time, total time in the operating room, operative charges, and total hospital charges were significantly reduced in the MIRP group. All 40 patients were cured of primary hyperparathyroidism. There were no recurrent laryngeal nerve injures in either group. The mean length of stay in the standard group was 1. 35 days; in the MIRP group, 65% of patients were discharged within 5 hours after surgery. The MIRP technique resulted in excellent cure rates for primary hyperparathyroidism while simultaneously decreasing operative time and hospital stays. These resulted in significant cost reductions without compromising patient safety. The technique may significantly change the management of primary hyperparathyroidism.

Although primary hyperparathyroidism is a physiologic disease, surgeons rely on anatomical characteristics (gross and histologic) to determine appropriate operative decisions. After the development of radioguided parathyroidectomy, we hypothesized that the amount of radioactivity contained within resected tissue would be the only information needed to establish the nature of the tissue and to determine a cure for the disease. A total of 1290 tissue specimens were obtained from 345 patients who had sporadic primary hyperparathyroidism. Ex-vivo radioactivity, in counts per second, was measured in parathyroid and other tissues within 3.5 hours of sestamibi injection. Background radioactivity was measured after tissue excision, and ratios were calculated. Lymph nodes, normal parathyroids, and fat never contained more than 2.2% of background radioactivity, whereas thyroid and hyperplastic parathyroids contained 5.5% and 7.5%, respectively, and never more than 16%. In contrast, adenomas contained 59% +/- 9% of background radioactivity (P < .000001 vs all other tissues), with a range of 18% to 136%. Radioactive ratios are an instantaneous measure of metabolic activity, thereby determining parathyroid function. Any excised tissue containing more than 20% of background radioactivity in a patient with a positive sestamibi scan result is a solitary parathyroid adenoma. This alleviates the need to identify other glands, obtain frozen sections, or measure serum parathyroid hormone levels intraoperatively.