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

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 Overview

• Status: Unknown
• Conditions: Endometrial Diseases
• Intervention / Treatment: Diagnostic test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Xiaofeng YANG; Email: yxf73@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with vaginal bleeding

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1; Endometrial Benign Disease	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.
Group2; Endometrial Cancer and Precancerous Lesions	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ultrasonography of endometrium	The ultrasonography of endometrium included shape, boundary and echo.	From March 2019 to December 2019
The endometrial thickness	The endometrial thickness in centimeter.	From March 2019 to December 2019
The blood flow index of endometrium	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).	From March 2019 to December 2019

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: Xiaofeng YANG, Doctor, The First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 4, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: XJTU1AF-CRF-2016T-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No