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临床试验/NCT03558321
NCT03558321
已完成
不适用

Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人2014年6月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Postmenopausal Bleeding
发起方
Cairo University
入组人数
100
试验地点
1
主要终点
endometrial pathology
状态
已完成
最后更新
7年前

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 For the level of HE4: 5 ml of venous blood were withdrawn from all patients.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. After hysteroscopy and biopsy, 2 patient proved to have cervical malignancy, 2 patients were unfit for open surgery, and another 6 patients did not show up after. These 10 patients were excluded from the study leaving 90 patients eligible for final analysis . 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.

注册库
clinicaltrials.gov
开始日期
2014年6月
结束日期
2018年5月
最后更新
7年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Ahmed Maged

professor

Cairo University

入排标准

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

结局指标

主要结局

endometrial pathology

时间窗: 3 days after hystroscopy

pathological examination of the endometrial tissue

研究点 (1)

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