Novel Approach to Outpatient Endometrial Biopsy to Detect Endometrial Cancer

Abstract

Objective: Currently there is no consensus on the best device and technique for obtaining endometrial biopsies to rule out cancer. Outpatient methods available include aspiration devices (Pipelle) and disruption devices (Tao brush). This study evaluated a new device which combines Global endometrial Disruption using a brush with a built in suction Process (GDP-Tao). Design: Prospective blinded comparison of a new device histology result compared to the final hysterectomy pathologic diagnosis. Materials and Methods: Endometrial biopsies were collected using the GDP-Tao from fresh uteri hysterectomy specimens after completion of surgery. Results of the GDP-Tao were compared to final hysterectomy pathology. Specificity and sensitivity, positive and negative predictive values were calculated. Result: Based on a sample size calculation, 42 patients were included in this study. Endometrial tissue adequate for diagnosis was obtained in 93% (39/42) biopsies. Classifying atypia as a positive result, the sensitivity of the new device was 96% (23/24) with specificity of 87% (13/15). The positive predictive value was 92% (23/25) and the negative predictive value 93% (13/14). There were 2 non-diagnostic (ND) samples from GDP-Tao with final pathology of benign endometrium. One specimen was ND on both GDP-Tao and final pathology due to absence of tissue after prior endometrial ablation. When stratified by uterine size, benign or malignant, the results were similar. Conclusion: Our validation study showed encouraging result for the GDP-Tao, which combines tissue disruption and aspiration into a single process. The device provides a reliable means of obtaining adequate sample to accurately detect endometrial cancer with a high negative and positive predictive value.