ES Sampler, a minimally invasive endometrial sampling tool that obtains specimens suitable for both cytological and histological analysis
Abstract
Aim
Conventional endometrial examination by dilatation and curettage (D&C) is not accepted by many patients because it is associated with pain and risk of injury and typically requires anesthesia and hospitalization. While several less invasive endometrial screening tools have been developed, their diagnostic value is generally inferior to D&C. Therefore, the purpose of this study was to evaluate the effectiveness of a new, minimally invasive device, called the ES Sampler, for outpatient endometrial screening.
Methods
This was a single‐blind study of 96 patients (age: 36.8 ± 8.1 years) who attended Peking Union Medical College Hospital from March 2015 to August 2016. Specimens were collected from each participant using the ES Sampler, followed by traditional D&C by hysteroscopy, and evaluated by histology and/or cytology. The sampling adequacy, sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy were compared, and patient acceptability was assessed.
Results
Compared to traditional D&C, the ES Sampler exhibited 99.0% sampling adequacy, and the combined (histology and cytology) results demonstrated 88.9% sensitivity, 95.6% specificity, 88.9% positive predictive value, 95.6% negative predictive value, and 93.7% accuracy. Moreover, the majority of study participants reported mild or no pain associated with the ES Sampler, and blood loss was minimal.
Conclusions
Our findings suggest that the minimally invasive ES Sampler is a reliable and accurate endometrial screening tool that is easily accepted by patients. The ES Sampler could be useful for screening high‐risk patients who may need further, more invasive examination, thereby conserving medical resources and minimizing patient discomfort.