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

Endometrial Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03289468
• Other study ID #: XJTU1AF-CRF-2016T-14
• Status: Recruiting
• Start date: July 10, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xiaofeng YANG, Doctor
• Phone: 0086-18602900810
• Email: yxf73[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Diseases
• Uterine Diseases

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The ultrasonography of endometrium	The ultrasonography of endometrium included shape, boundary and echo.	From March 2019 to December 2019
Secondary	The endometrial thickness	The endometrial thickness in centimeter.	From March 2019 to December 2019
Secondary	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