Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases

Overview

The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 30, 2019

Detailed Description

The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.

Interventions

  • Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler
    • The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.

Arms, Groups and Cohorts

  • Group1
    • Endometrial Benign Disease
  • Group2
    • Endometrial Cancer and Precancerous Lesions

Clinical Trial Outcome Measures

Primary Measures

  • The endometrial vascularization index
    • Time Frame: From March 2019 to December 2019
    • The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).

Secondary Measures

  • The ultrasonography of endometrium
    • Time Frame: From March 2019 to December 2019
    • The ultrasonography of endometrium included shape, boundary and echo.
  • The endometrial thickness
    • Time Frame: From March 2019 to December 2019
    • The endometrial thickness in centimeter.
  • The blood flow index of endometrium
    • Time Frame: From March 2019 to December 2019
    • The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI).

Participating in This Clinical Trial

Inclusion Criteria

  • Postmenopausal women with vaginal bleeding Exclusion Criteria:

  • Vaginal bleeding caused by hematological system diseases or genitals outside the uterus – Uterine bleeding caused by other organ cancers metastasize to the uterus

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital Xi’an Jiaotong University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiaofeng YANG, Doctor, Study Director, The First Affiliated Hospital of Xian Jiaotong University
  • Overall Contact(s)
    • Xiaofeng YANG, Doctor, 0086-18602900810, yxf73@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.