The application of endometrial sampler SAP-1 to screening of endometrial cancer in postmenopausal women: A diagnostic test study

Abstract

With cytology for screening cervical cancer providing a successful reference, endometrial cancer screening has attracted more attentions recently. The objective of this study is to evaluate the application of endometrial sampler SAP-1 as a screening tool to detect endometrial cancer among postmenopausal women. From August 2018 to February 2021, 54 postmenopausal women were hospitalized for undergoing hysteroscopy examination. Before the procedure, endometrial samples were collected by the method of SAP-1. The histological results were compared with those by hysteroscopy sampling. The satisfactory rate for the endometrial specimen by SAP-1 sampling was 88.9%. The sensitivity, specificity and accuracy rate of SAP-1 sampling for diagnosing the cancer or precancerous lesions of endometrium were 87.5%, 100% and 97.9%, respectively. Among these patients, whether they had bleeding symptoms, endometrial thickening or intrauterine occupying lesions, risk factors for endometrial cancer or not, the diagnostic coincidence rate of SAP-1 sampling was over 96%, and the differences were not statistically significant (P>0.05). In conclusions, in postmenopausal women, SAP-1 sampling is an ideal screening method, regardless of whether the patients have bleeding symptoms, endometrial thickening or intrauterine occupying lesions, endometrial cancer risk factors. The diagnostic coincidence rate is quite high, but it still needs large sample study to verify.

The Evaluation of Endometrial Sampler SAP-1 in Screening Patients With General Risk of Endometrial Cancer: A Diagnostic Test Study

“…Our research team has recently used SAP-1 to screen EC among postmenopausal women (2). As well as the current results of this study, the sample satisfaction rate and diagnostic coincidence rate of SAP-1 sampling are ideally more than 90%, consistent with the literature reports (17,18), and similar to other types of endometrial sampling devices (19), And this method has been widely recognized by Chinese experts (7). Naturally, most ECs evolve relatively slowly, and most EC patients are diagnosed in the early stage.…”

“…According to the consensus of Chinese experts, EC screening is recommended to be conducted among high-risk and risk-increasing populations, while the general-risk population, even with symptoms, is not within the scope of screening. Obtaining microscale endometrial tissue for pathological examination through endometrial biopsy by method of circular sampling device (SAP-1, shown in Figure 1) is an effective way for EC screening and early diagnosis (7). Although the prevalence of EC in the general-risk population is far lower than that in the high-risk and risk-increasing population, once missed diagnosis happens, it will be detrimental to the patient's psychology and physiological well-being, and even impact the prognosis.…”

“…hysteroscopy, including abnormal uterine bleeding and/ or abnormal echo images in the uterine cavity indicated by ultrasound, and had no operation contraindications. Exclusion criteria: patients with at least one of the following conditions are considered as high-risk or riskincreasing population according to "Advices on standards of EC screening" issued in 2020 (7) Endometrial Sampling Methods Under intravenous anesthesia in operation room, surgical procedure steps were all performed by the same experienced gynecologist and as follows: (a) Use endometrial sampler SAP-1, manufactured by Saipu Jiuzhou Company, Beijing, China, to perform microscale endometrial sampling. The method of application can refer to our previous research report (8); (b) Undergo hysteroscopy routinely; (c) Perform diagnostic curettage or hysteroscopic electric resection, and collect endometrial specimens; (d) The specimens were sent to the Pathology Department, fixed with 10% Formaldehyde solution, embedded in paraffin, and stained with hematoxylin-eosin (HE).…”