Zhang Yinglan, Zhao Yu, Lang Jing He, Li Yuan
Department of Gynecology and Obstetrics, Beijing Chaoyang Hospital, Beijing, China.
Department of Pathology in Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China.
J Obstet Gynaecol Res. 2021 May;47(5):1854-1861. doi: 10.1111/jog.14697. Epub 2021 Feb 15.
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.
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.
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.
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.
传统的通过刮宫术(D&C)进行子宫内膜检查未被许多患者接受,因为它会带来疼痛和受伤风险,并且通常需要麻醉和住院。虽然已经开发了几种侵入性较小的子宫内膜筛查工具,但其诊断价值通常低于刮宫术。因此,本研究的目的是评估一种名为ES采样器的新型微创设备用于门诊子宫内膜筛查的有效性。
这是一项对96例患者(年龄:36.8±8.1岁)的单盲研究,这些患者于2015年3月至2016年8月在北京协和医院就诊。使用ES采样器从每个参与者收集样本,随后通过宫腔镜进行传统刮宫术,并通过组织学和/或细胞学进行评估。比较采样充分性、敏感性、特异性、阳性和阴性预测值以及诊断准确性,并评估患者的可接受性。
与传统刮宫术相比,ES采样器的采样充分率为99.0%,联合(组织学和细胞学)结果显示敏感性为88.9%,特异性为95.6%,阳性预测值为88.9%,阴性预测值为95.6%,准确性为93.7%。此外,大多数研究参与者报告使用ES采样器时疼痛轻微或无疼痛,且失血量极少。
我们的研究结果表明,微创的ES采样器是一种可靠且准确的子宫内膜筛查工具,易于被患者接受。ES采样器可用于筛查可能需要进一步进行更具侵入性检查的高危患者,从而节省医疗资源并将患者不适降至最低。