World Journal of Surgery

, Volume 20, Issue 1, pp 88-93

First online:

Optimal Surgery for Papillary Thyroid Carcinoma

  • Robert UdelsmanAffiliated withDivision of Endocrine and Oncologic Surgery, The Johns Hopkins University School of Medicine and The Johns Hopkins Thyroid Tumor Center, Baltimore, Maryland 21287, U.S.A.
  • , Edward LakatosAffiliated withDepartment of Statistics, G.D. Searle & Company, Skokie, Illinois 60077, U.S.A.
  • , Paul LadensonAffiliated withDivision of Endocrinology and Metabolism, The Johns Hopkins University School of Medicine and The Johns Hopkins Thyroid Tumor Center, Baltimore, Maryland 21287, U.S.A.

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Abstract. There has been a long, unresolved debate regarding the operation of choice for well differentiated carcinoma of the thyroid. We therefore analyzed the feasibility, scope, sample size, and length of follow-up required to determine the optimal operation for papillary thyroid carcinoma. A statistical approach was used to design a randomized prospective trial comparing the endpoints of complications, recurrence, and cause-specific mortality. A complication comparison trial is prohibitive owing to the large population required—approximately 12,000 randomized patients. A recurrence trial appears feasible based on sample size: approximately 360 to 800 patients with a 6 to 10-year follow-up. However, recurrence detection would be severely compromised in the lobectomy arm, and a unilateral lag-time bias would occur. A cause-specific mortality trial proves to be the least objectionable, although a large sample size (

n = 3100) would be required. Such a trial is critically dependent on the ability to select an appropriate endpoint. A cause-specific mortality trial proves to be the most objective and statistically valid endpoint.