Three-dimensional Power Doppler in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding
Primary Purpose
Postmenopausal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3 dimensional ultrasonography and Doppler
Sponsored by
About this trial
This is an interventional diagnostic trial for Postmenopausal Bleeding focused on measuring postmenopausal bleeding, ultrasound, power doppler, endometrium
Eligibility Criteria
Inclusion Criteria:
• Post-menopausal bleeding (occurred after at least 12 months of amenorrhea)
Exclusion Criteria:
- History of hormone administration in the last 6 months.
- Systemic diseases causing abnormal uterine bleeding as hematologic diseases and chronic medical diseases.
- Women who experienced artificial or induced menopause because of the use of tamoxifen or any type of hormone replacement therapy.
- Patients who take any anticoagulant drugs.
Sites / Locations
- kasr elaini hospital (Cairo university)Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
3 dimensional power Doppler
Arm Description
100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study and 3 dimensional ultrasonography and Doppler will be done for them
Outcomes
Primary Outcome Measures
the diagnostic performance of Vascularization index in detecting endometrial carcinoma
Vascularization index (VI) will be correlated to pathology report
Secondary Outcome Measures
the diagnostic performance of the endometrial volumes acquired by Three-Dimensional Ultrasound
endometrial volumes will be correlated to pathology report
the diagnostic performance of flow index (FI) in detecting endometrial carcinoma.
flow index will be correlated to pathology report
the diagnostic performance of vascularization-flow index (VFI) in detecting endometrial carcinoma.
vascularization-flow index (VFI) will be correlated to pathology report
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03543592
Brief Title
Three-dimensional Power Doppler in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding
Official Title
The Accuracy of Three-dimensional Power Doppler Ultrasound in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding Compared With the Endometrial Histopathology.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
100 women suffering post-menopausal bleeding will be included in the study. All the participants will undergo 3D Transvaginal Ultrasound to assess the endometrium and myometrium (for the presence of any focal lesions e.g. polypi) followed by 3D Power Doppler ultrasound assessment of the vascular indices: vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) and endometrial volumes.
The results of the ultrasound and Doppler indices will be correlated to the histopathological examination of specimens collected following fractional curettage or hysterectomy.
Detailed Description
100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study.
After obtaining an informed consent entailing the explanation of the study and its aim, all participants will undergo the following; full history taking (including full menstrual history and the date of menopause), complete physical examination, laboratory investigations (complete blood count, liver function tests, kidney function tests and a coagulation profile). Baseline 2D transvaginal ultrasound will be done to measure endometrial thickness and to detect presence of any endometrial and myometrial focal lesions. 3D-transvaginal ultrasonography will be done to acquire multi-planner view of the uterine cavity and detect presence or absence of any cavitary or myometrial lesions and acquire endometrial volumes. This will be followed by 3D Power Doppler Ultrasound assessment of the vascular indices namely; vascularization index (VI), flow index (FI) and vascularization-flow index (VFI).
Transvaginal sonography will be performed for all patients using Voluson 730 PRO V transvaginal volumetric probe transducer with frequency range of 5-8 MHz equipped with color, power and pulsed Doppler capabilities. First, conventional gray-scale sonography will be performed to obtain longitudinal and transverse sections of the uterus. Maximum endometrial thickness (double-layer) will be measured in the longitudinal plane with the detection of any focal lesions.
For Three-Dimensional Ultrasound: Once the B - mode had been completed, three-dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. The probe will be kept steady, the patient will be asked to hold breath and volume mode will be switched on. With the use of the medium line density, the typical acquisition time will be between 4 and 10 seconds. Visualization of the endometrium in the three planes will be done to detect endometrial cavity. Endometrial margin, echogenicity and presence of intrauterine fluid will be examined to notice the presence of any heterogenic pattern, irregularity, asymmetry in the margin or local thickening denoting the presence of polyp, endometrial hyperplasia, or carcinoma. The myometrium will be also examined in the three planes to detect any other focal lesion e.g. Fibroid or Adenomyosis.
For Power Doppler Study, the power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). Power Doppler settings will be set to achieve maximum sensitivity for detecting low velocity flow without noise. Once the vessels have been identified, the pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs. Only endometrial and endometrial-myometrial interface vessels were included.
The patient will then be admitted for either a D and C operation (Endometrial curettage) or for Total Abdominal Hysterectomy. All removed tissues will be sent for histopathological examination of the endometrium or of any pathological uterine lesion. Pathological examination results will be correlated to ultrasound (2D and 3D) and Doppler findings,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Bleeding
Keywords
postmenopausal bleeding, ultrasound, power doppler, endometrium
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 dimensional power Doppler
Arm Type
Other
Arm Description
100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study and 3 dimensional ultrasonography and Doppler will be done for them
Intervention Type
Diagnostic Test
Intervention Name(s)
3 dimensional ultrasonography and Doppler
Intervention Description
Three-Dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. Visualization of the endometrium and myometrium in the three planes will be done to detect endometrial cavity and any lesions. The power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). The pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs.
Primary Outcome Measure Information:
Title
the diagnostic performance of Vascularization index in detecting endometrial carcinoma
Description
Vascularization index (VI) will be correlated to pathology report
Time Frame
within 24 hours before the surgical procedure
Secondary Outcome Measure Information:
Title
the diagnostic performance of the endometrial volumes acquired by Three-Dimensional Ultrasound
Description
endometrial volumes will be correlated to pathology report
Time Frame
within 24 hours before the surgical procedure
Title
the diagnostic performance of flow index (FI) in detecting endometrial carcinoma.
Description
flow index will be correlated to pathology report
Time Frame
within 24 hours before the surgical procedure
Title
the diagnostic performance of vascularization-flow index (VFI) in detecting endometrial carcinoma.
Description
vascularization-flow index (VFI) will be correlated to pathology report
Time Frame
within 24 hours before the surgical procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Post-menopausal bleeding (occurred after at least 12 months of amenorrhea)
Exclusion Criteria:
History of hormone administration in the last 6 months.
Systemic diseases causing abnormal uterine bleeding as hematologic diseases and chronic medical diseases.
Women who experienced artificial or induced menopause because of the use of tamoxifen or any type of hormone replacement therapy.
Patients who take any anticoagulant drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
moutaz elsherbini, MD
Phone
+2 01001588300
Email
mizosherbini@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sally El-Attar, MSc
Email
dr_sally_elattar@yahoo.com
Facility Information:
Facility Name
kasr elaini hospital (Cairo university)
City
Cairo
ZIP/Postal Code
115431
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOUTAZ ELSHERBINI, MD
Phone
(+2)01001588300
Email
mizosherbini@yahoo.com
First Name & Middle Initial & Last Name & Degree
MOUTAZ ELSHERBINI, md
12. IPD Sharing Statement
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Three-dimensional Power Doppler in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding
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