Accuracy of the Wallach Endocell endometrial cell sampler in diagnosing endometrial carcinoma and hyperplasia

AbstractAim:  To assess the accuracy of the Wallach Endocell endometrial cell sampler in diagnosing endometrial carcinoma and hyperplasia.Methods:  Women aged over 35 years old with abnormal uterine bleeding who came to Chiang Mai University Hospital between June 2008 and June 2009 were invited to participate in this study if they were candidates for the fractional curettage procedure. All patients underwent endometrial sampling prior to endometrial curettage. The endometrial samples from both procedures were separately evaluated by different pathologists. The accuracy of the Wallach Endocell device in diagnosing endometrial carcinoma and hyperplasia was calculated by comparison with the final histology. When the results from both procedures were not identical, the final diagnosis was reported according to the consensus of the pathologists. Tissue adequacy was also determined.Results:  During the study period, 202 patients were recruited into this study. The sensitivity, specificity, false negative rate and false positive rate of the Wallach Endocell in diagnosing endometrial carcinoma and hyperplasia were 60.00%, 99.46%, 40.00% and 0.54%, respectively. Of 13 patients with endometrial hyperplasia, six were not detected by the Wallach Endocell device. All endometrial carcinomas were detected by the endometrial sampling procedure. Tissue adequacy from the Wallach Endocell device was 85.6%. The positive predictive value and negative predictive value were 95.00% and 92.85%, respectively.Conclusions:  The Wallach Endocell is an effective device for diagnosing endometrial carcinoma; however, the results of endometrial sampling should be interpreted with caution because of a high false negative rate in detecting endometrial hyperplasia.