Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- endometrial pathology
研究概览
简要总结
All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.
full history, general and local examination were done. Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured. All women underwent hystrospopic guided endometrial biopsy. Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.
详细描述
All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.
Full history was taken , the number of episodes of postmenopausal bleeding, and previous investigations and current medications), general examination was performed and local examination was performed for all patients.
Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces by using electronic calipers. If there was fluid in the uterine cavity it was recorded. Suspected polyp was also recorded.
For the level of HE4: 5 ml of venous blood were withdrawn from all patients. The samples were left to clot. The separated sera were stored at -20˚ until all samples were obtained. Frozen samples were allowed to reach room temperature prior to use. Samples were then mixed thoroughly by gently inverting multiple times before analysis. HE4 was quantitatively assayed using the enzyme immunoassay (EIA) method (Fujirebio Diagnostics, Inc. Göteborg, Sweden). The functional sensitivity of the HE4 EIA is ≤ 25pM. The analytical specificity is 100 ± 15%.
All patients were then submitted to hysteroscopy under general anesthesia and endometrial biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm
排除标准
- •• History of other Malignancies
- •Patients on chemo and/or radiotherapy
- •Patients on tamoxifen
- •Patients unfit for surgical intervention
- •Patients on HRT or other hormonal treatment
研究组 & 干预措施
post menopausal bleeding
women with postmenopausal bleeding and endometrial thickness more than 5 mm
干预措施: Hysteroscopic guided fractional curretage (Procedure)
post menopausal bleeding
women with postmenopausal bleeding and endometrial thickness more than 5 mm
干预措施: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection (Procedure)
结局指标
主要结局
endometrial pathology
时间窗: 3 days after hystroscopy
pathological examination of the endometrial tissue
次要结局
未报告次要终点