Objective: In centres in which intra-operative frozen section (FS) analysis is not performed, 'apparent' early-stage ovarian cancer diagnosed after surgery on paraffin section may require further restaging laparotomy or adjuvant chemotherapy. Previous studies on FS analysis have reported high sensitivity, specificity and overall accuracy. The objective of this article is to present the largest published dataset on the accuracy of FS analysis over an 11-year period from a single institution.
Design: Diagnostic test accuracy.
Setting: Northern Gynaecological Oncology Centre and Department of Cellular Pathology, Gateshead, UK.
Population: 1439 intra-operative FS analyses performed between January 2000 and December 2010 for suspected ovarian cancer.
Methods: Prospectively collected data on FS analysis were compared with gold standard paraffin section.
Main outcome measures: Sensitivity, specificity, likelihood ratios and post-test probability.
Results: The overall sensitivity and specificity of FS analysis were 91.2% and 98.6%, respectively. Positive and negative likelihood ratios were 64.7% and 0.09%, respectively. The pre-test probability of an ovarian tumour being borderline or malignant was 45.8%. When FS analysis was reported to be positive, the post-test probability increased to 98% (confidence interval, 97-99%). Conversely, when FS analysis was reported to be negative, the post-test probability decreased to 7% (confidence interval, 6-9%). The majority of false test results were either borderline tumours or of mucinous differentiation.
Conclusions: Intra-operative FS analysis has excellent diagnostic test accuracy and assists gynaecological oncologists to perform the appropriate surgery in 95% of cases, thereby preventing the morbidity of surgical staging in benign cases and the morbidity of restaging procedures or chemotherapy in early-stage malignant tumours.
© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.