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Combining endometrium sampling device and SurePath preparation to screen for endometrial carcinoma: a validation study.

Wen J, Chen R, Zhao J, Dong Y, Yang X, Liao QP - Chin. Med. J. (2015)

Bottom Line: Histological samples were processed in routine pathology and stained by hematoxylin and eosin.Adequate specimens for cytology were obtained from 1458/1541 patients (96.3%), while adequate samples for pathology were obtained from 285/375 patients (76%).However, for postmenopausal women, 1006 of 1045 cytology (86.3%) were adequate, 153 of 238 histology (64.3%) were adequate, it was easier to collect cytological specimens than histological specimens (P < 0.05).

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.

ABSTRACT

Background: The aim of this study was to compare specimen adequacy of SAP-1 provided for cytology with that of dilation and curettage (D & C) or hysteroscopy for histology, and evaluate the accuracy of combining endometrium sampling by SAP-1 and liquid-based cytology using SurePath preparation for screening endometrial carcinoma and its precursor.

Methods: Endometrial specimens from women (n = 1514) with risk factors were obtained using an SAP-1 device for cytological analysis; histological samples were obtained from 375 of these women who underwent D & C or hysteroscopy. Cytological specimens were prepared to liquid-based smear using SurePath technology and stained by Papanicolaou. Histological samples were processed in routine pathology and stained by hematoxylin and eosin.

Results: Adequate specimens for cytology were obtained from 1458/1541 patients (96.3%), while adequate samples for pathology were obtained from 285/375 patients (76%). However, for postmenopausal women, 1006 of 1045 cytology (86.3%) were adequate, 153 of 238 histology (64.3%) were adequate, it was easier to collect cytological specimens than histological specimens (P < 0.05). The accuracy of endometrial cytology for detecting endometrial carcinoma and its precursor was 92.4% (sensitivity, 73%; specificity, 95.8%; positive predictive value, 75%; and negative predictive value, 95.3%).

Conclusions: Endometrial cytology using SAP-1 sampling and SurePath preparation may be a reliable approach for screening patients with endometrial carcinoma and its precursor.

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Related in: MedlinePlus

The SAP-1 sampling device.
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Figure 1: The SAP-1 sampling device.

Mentions: This study was performed from November 2011 to May 2014 at the Obstetrics and Gynecology Department of Peking University First Hospital and it had been approved by the hospital ethics committee. Women had at least only one risk factors were enrolled into this study. The risk factors included: (1) Age ≥ 40 years; (2) intrinsically high estrogen including polycystic ovarian syndrome and ovarian tumors with an abnormal level of estrogen such as granulosa cell tumors; (3) extrinsically high estrogen including hormone replacement therapy and postoperative breast cancer patients taking tamoxifen; (4) high body mass index (BMI) ≥25 kg/m2; (5) hypertension, hyperlipidemia and diabetes; (6) family history of cancer including hereditary nonpolyposis colon cancer, Lynch syndrome, and first-degree relatives with gynecologic tumor; (7) history of radiation and smoking; (8) abnormal uterus bleeding (AUB), especially postmenopausal vaginal bleeding; (9) abnormal endometrium assessed by ultrasound as follows: Thickness (postmenopausal women ≥4 mm or menopausal women ≥20 mm), occupation disease of the uterine cavity or heterogeneous. While patients with following conditions were excluded out of this study: (1) Ultrasound scanning suggested uterus cavity was distorted by multiple uterine myomas or adenomyoma; (2) patients with intra-uterine device. 1514 patients were consulted to entry into this study. They provided written informed consent and underwent an ECT using the direct sampler SAP-1 device (Saipujiuzhou Corporation, Beijing, China) [Figure 1]. This device was patented and received permission to use it in our clinic in China.


Combining endometrium sampling device and SurePath preparation to screen for endometrial carcinoma: a validation study.

Wen J, Chen R, Zhao J, Dong Y, Yang X, Liao QP - Chin. Med. J. (2015)

The SAP-1 sampling device.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4834777&req=5

Figure 1: The SAP-1 sampling device.
Mentions: This study was performed from November 2011 to May 2014 at the Obstetrics and Gynecology Department of Peking University First Hospital and it had been approved by the hospital ethics committee. Women had at least only one risk factors were enrolled into this study. The risk factors included: (1) Age ≥ 40 years; (2) intrinsically high estrogen including polycystic ovarian syndrome and ovarian tumors with an abnormal level of estrogen such as granulosa cell tumors; (3) extrinsically high estrogen including hormone replacement therapy and postoperative breast cancer patients taking tamoxifen; (4) high body mass index (BMI) ≥25 kg/m2; (5) hypertension, hyperlipidemia and diabetes; (6) family history of cancer including hereditary nonpolyposis colon cancer, Lynch syndrome, and first-degree relatives with gynecologic tumor; (7) history of radiation and smoking; (8) abnormal uterus bleeding (AUB), especially postmenopausal vaginal bleeding; (9) abnormal endometrium assessed by ultrasound as follows: Thickness (postmenopausal women ≥4 mm or menopausal women ≥20 mm), occupation disease of the uterine cavity or heterogeneous. While patients with following conditions were excluded out of this study: (1) Ultrasound scanning suggested uterus cavity was distorted by multiple uterine myomas or adenomyoma; (2) patients with intra-uterine device. 1514 patients were consulted to entry into this study. They provided written informed consent and underwent an ECT using the direct sampler SAP-1 device (Saipujiuzhou Corporation, Beijing, China) [Figure 1]. This device was patented and received permission to use it in our clinic in China.

Bottom Line: Histological samples were processed in routine pathology and stained by hematoxylin and eosin.Adequate specimens for cytology were obtained from 1458/1541 patients (96.3%), while adequate samples for pathology were obtained from 285/375 patients (76%).However, for postmenopausal women, 1006 of 1045 cytology (86.3%) were adequate, 153 of 238 histology (64.3%) were adequate, it was easier to collect cytological specimens than histological specimens (P < 0.05).

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.

ABSTRACT

Background: The aim of this study was to compare specimen adequacy of SAP-1 provided for cytology with that of dilation and curettage (D & C) or hysteroscopy for histology, and evaluate the accuracy of combining endometrium sampling by SAP-1 and liquid-based cytology using SurePath preparation for screening endometrial carcinoma and its precursor.

Methods: Endometrial specimens from women (n = 1514) with risk factors were obtained using an SAP-1 device for cytological analysis; histological samples were obtained from 375 of these women who underwent D & C or hysteroscopy. Cytological specimens were prepared to liquid-based smear using SurePath technology and stained by Papanicolaou. Histological samples were processed in routine pathology and stained by hematoxylin and eosin.

Results: Adequate specimens for cytology were obtained from 1458/1541 patients (96.3%), while adequate samples for pathology were obtained from 285/375 patients (76%). However, for postmenopausal women, 1006 of 1045 cytology (86.3%) were adequate, 153 of 238 histology (64.3%) were adequate, it was easier to collect cytological specimens than histological specimens (P < 0.05). The accuracy of endometrial cytology for detecting endometrial carcinoma and its precursor was 92.4% (sensitivity, 73%; specificity, 95.8%; positive predictive value, 75%; and negative predictive value, 95.3%).

Conclusions: Endometrial cytology using SAP-1 sampling and SurePath preparation may be a reliable approach for screening patients with endometrial carcinoma and its precursor.

Show MeSH
Related in: MedlinePlus