Optimal surgery for papillary thyroid carcinoma.
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.
Udelsman
R
R
Division of Endocrine and Oncologic Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.
Lakatos
E
E
Ladenson
P
P
D002291:Carcinoma, Papillary / Q000601:surgery*; D006801:Humans; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D013964:Thyroid Neoplasms / Q000601:surgery*; D013965:Thyroidectomy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome