title: Randomized prospective evaluation of frozen-section analysis for follicular neoplasms of the thyroid.
abstract: OBJECTIVE
  To evaluate the clinical utility of frozen section in patients with follicular neoplasms of the thyroid in a randomized prospective trial.
  
  
  BACKGROUND
  The finding of a follicular neoplasm on fine-needle aspiration prompts many surgeons to perform intraoperative frozen section during thyroid lobectomy. However, the focal distribution of key diagnostic features of malignancy contributes to a high rate of noninformative frozen sections.
  
  
  METHODS
  The series comprised 68 consecutive patients with a solitary thyroid nodule in whom fine-needle aspiration showed a follicular neoplasm. Patients were excluded for bilateral or nodal disease, extrathyroidal extension, or a definitive fine-needle aspiration diagnosis. Final pathologic findings were compared with frozen sections, and cost analyses were performed.
  
  
  RESULTS
  Sixty-one patients met the inclusion criteria. Twenty-nine were randomized to the frozen-section group and 32 to the non-frozen-section group. In the non-frozen-section group, one patient was excluded when gross examination of the specimen was suggestive of malignancy and a directed frozen section was diagnostic of follicular carcinoma. Frozen-section analysis rendered a definitive diagnosis of malignancy in 1 of 29 (3.4%) patients, who then underwent a one-stage total thyroidectomy. In the remaining 28 patients, frozen section showed a "follicular or Hürthle cell neoplasm." Permanent histology demonstrated well-differentiated thyroid cancer in 6 of these 28 patients (21%). Of the 31 patients in the non-frozen-section group, 3 (10%) showed well-differentiated thyroid carcinoma on permanent histology. Complications were limited to one transient unilateral vocal cord dysfunction. All but one patient had a 1-day hospital stay. There were no significant differences between the groups in surgical time or total hospital charges; however, the charge per informative frozen section was approximately $12,470.
  
  
  CONCLUSIONS
  For the vast majority of patients (96.4%) with follicular neoplasms of the thyroid, frozen section is neither informative nor cost-effective.
authors.affiliation: Departments of Surgery and Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. rudelsma@jhmi.edu
authors.forename: R
authors.initials: R
authors.lastname: Udelsman
authors.forename: W H
authors.initials: WH
authors.lastname: Westra
authors.forename: P I
authors.initials: PI
authors.lastname: Donovan
authors.forename: T A
authors.initials: TA
authors.lastname: Sohn
authors.forename: J L
authors.initials: JL
authors.lastname: Cameron
mesh_terms: D018263:Adenocarcinoma, Follicular / Q000473:pathology* / Q000601:surgery; D000328:Adult; D003362:Cost-Benefit Analysis; D005260:Female; D005629:Frozen Sections / Q000191:economics; D006801:Humans; D008297:Male; D008396:Maryland; D011446:Prospective Studies; D013964:Thyroid Neoplasms / Q000473:pathology* / Q000601:surgery; D013965:Thyroidectomy