Clinical trial NCT03289468: Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
Official title: Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Diseases
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with vaginal bleeding

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.

Eligibility criteria: 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

Primary outcomes:
measure: The endometrial vascularization index
timeFrame: From March 2019 to December 2019
Secondary outcomes:
measure: The ultrasonography of endometrium
timeFrame: From March 2019 to December 2019
measure: The endometrial thickness
timeFrame: From March 2019 to December 2019
measure: The blood flow index of endometrium
timeFrame: From March 2019 to December 2019
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of Xian Jiaotong University
name: Xiaofeng YANG, Doctor
role: STUDY_DIRECTOR
References: