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

• Conditions: Endometrial Diseases
• Interventions: Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

• Registration Number: NCT03289468
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-15
• Study Start: 2017-07-10
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Status Verified: 2018-09
• Last Update Submitted: 2019-08-04
• Last Update Posted: 2019-08-07
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group2	Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler	Endometrial Cancer and Precancerous Lesions
Group1	Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler	Endometrial Benign Disease

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China