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

NCT03289468 — Unknown, 200 participants, First Affiliated Hospital Xi'an Jiaotong University

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RegistryNCT03289468
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorFirst Affiliated Hospital Xi'an Jiaotong University (Other)
ConditionsEndometrial Diseases
InterventionsVoluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler (Diagnostic test)
Datesstart 2017-07-10, primary completion 2019-12-30 (estimated), completion 2019-12-30 (estimated), first posted 2017-09-21, last updated 2019-08-07
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group1Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerEndometrial Benign Disease
Group2Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerEndometrial Cancer and Precancerous Lesions
  • Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler (Diagnostic test): 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • The ultrasonography of endometrium [From March 2019 to December 2019]: The ultrasonography of endometrium included shape, boundary and echo.
  • The endometrial thickness [From March 2019 to December 2019]: The endometrial thickness in centimeter.
  • 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).

+Eligibility

Sex: Female, ages: 45 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ShaanxiChinaRecruiting

+Investigators

  • Xiaofeng YANG, Doctor, Study director, First Affiliated Hospital Xi'an Jiaotong University

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