Determination of Performance Characteristics of Endometrial Tao Brush in the Detection of Endometrial Cancer and Atypical Hyperplasia

Abstract

Endometrial cancer is the most frequent gynecologic malignancy in countries that are developed with 54,870 new cases projected in the United States in 2022. In Kenya, cancer of the uterine corpus has an incidence of 1.7%. It is usually common among postmenopausal women with an average age of 60 years when they are diagnosed and early detection is crucial for favorable outcomes. In Kenya there is no screening tool for Endometrial Cancer. The brush is easy to use, can be used in an ambulatory setting without anesthesia, and is less painful than the dilatation and curettage technique which is the gold standard. The current study aimed at determining the performance characteristics of Endometrial Tao brush in the detection of Endometrial Cancer and Hyperplasia with atypia using Manual Liquid Based Cytology Samples and Conventional cytology samples compared with the biopsies from Dilatation and Curettage. Sixty women were evaluated for Hyperplasia with atypia and Endometrial Cancer using the Endometrial Tao brush and Dilatation and Curettage Method. Manual Liquid Based Cytology specimens were fixed in a liquid fixative which was formulated (containing 10% formalin, sodium chloride, isopropyl alcohol, and sodium citrate) and then vortexed. 2mls of the polymer solution was added to the deposit and a smear was made on the slide, it was then oven dried and fixed with 95% alcohol for 15 minutes. The slides were then stained with papanicolaou stain and examined. The Conventional cytology samples were fixed with 95% alcohol for 15 minutes, stained with papanicolaou stain and then examined. Histology samples were fixed with 10% formalin and then underwent dehydration, clearing, infiltration, embedding, sectioning, staining with Hematoxylin and Eosin and finally examination under the microscope. Cytological findings were categorized as Unsatisfactory for evaluation, Negative endometrium, Endometrial hyperplasia without atypia, hyperplasia with atypia and Malignant neoplasms. Histopathological results were used as the reference for determining the performance characteristics of cytological smears. The agreement level between the two methods was determined using Cohen’s Kappa test. Histopathological diagnoses from the 60 patients comprised 14 (23%) Endometrial Cancers, 8 (13%) Complex hyperplasia with atypia, 16 (27%) Simple and mild hyperplasia without atypia, 3 (5%) Non-Diagnostic, and 19 (32%) patients with Negative Endometrial Histology. The Manual Liquid Based Cytology specimens diagnosed as Malignant, Atypical hyperplasia, Endometrial hyperplasia without atypia, Unsatisfactory, and Negative were 12 (20%), 9 (15%), 16 (27%), 3 (5%), and 20 (33%) specimens correspondingly. The Conventional Cytology specimens diagnosed as Malignant, Atypical hyperplasia, Endometrial hyperplasia without atypia, Unsatisfactory, and Negative were 15 (25%), 8 (13%), 13 (22%), 6 (10%), and 18 (30%) specimens accordingly. The specificity and sensitivity of cytology using Tao Brush for detecting endometrial cancer and hyperplasia with atypia were 100% and 95.45% for the Manual Liquid Based Cytology specimens and 95% and 90.91% for Conventional specimens respectively. The Cohen’s kappa value was 0.912 and 0.891 for Manual Liquid Based Cytology specimens and Conventional specimens respectively. Given the auspicious specificity and sensitivity of the endometrial Tao brush in this current study, direct sampling of the endometrium with the Tao brush is a useful tool in the assessment of unusual uterine bleeding, particularly in the detection of cancer of the endometrium. This therefore will improve treatment outcomes for patients with Endometrial cancer and prolong the quality of life.