Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

Ovarian Endometrioma Clinical Trial

Official title:

Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05104086
• Other study ID #: MS.19.09.821
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2020
• Est. completion date: December 25, 2021

Study information

• Verified date: September 2021
• Source: Mansoura University
• Contact: hala hafez, resident
• Phone: 00201027292006
• Email: halahafez193[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts

Description:

The participants will be subjected to:

• Personal, Obstetric and gynecological History taking.

• Clinical examination.

• B-mode ultrasonography was performed to characterize the adnexal masses morphologically.

• Color Doppler ultrasound.

• Grayscale and elastographic ultrasound examination, which will be done using acoustic radiation force impulse (ARFI) imaging with virtual touch quantification (VTQ). Five consecutive measurements were recorded for each lesion from the region identified as the region of interest (ROI) and the median of these measurements was recorded as the shear wave velocity (SWV) value of the lesion. In virtual touch quantification (VTQ) the shear wave speed is expressed in m/s. Only numerical results will be taken into consideration.

. Realtime elastographic and B-mode images simultaneously will appear as a two-panel image. Elastogram appeared in the region of interest (ROI) box to determine the target ovarian lesion and surrounding tissue, then elasticity colour code will be classified in 5 patterns : pattern 1, an absent or a very small hard area; pattern 2, hard area 45 per cent; pattern 4, peripheral hard and central soft areas; pattern 5, hard area occupying entire solid component with or without soft rim. Strain index will be analyzed, which will be obtained by comparing the absolute strain value of solid component of ovarian cyst with that of surrounding soft tissue.

• The invistigator will reevaluate the lesions 4 weeks after the initial assessment to see the possible changes in the size and/or configuration of the lesions with B-mode and elastographic ultrasonography.

• Lesion will be evaluated as endometriomas and referred for surgery when shows no significant changes in size and configuration.

• Hemorrhagic cyst diagnosis will be made if the lesion had resolved on follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

Inclusion Criteria:

• Patient suspected to have endometrioma or hemorrhagic ovarian cysts.

Exclusion Criteria:

• Simple cysts which were defined as a sonolucent thin-walled (<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections [12].

• Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma

Intervention

Device:
• ultrasound elastography
strain ratio and resistivity index

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts	the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst	4 weeks