Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

Mansoura University

Status: Unknown

Conditions: Ovarian Endometrioma

Treatments: Device: ultrasound elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT05104086

MS.19.09.821

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 estimated patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

evaluate the value of ultrasound elastography in dignosis of endometriomas

Active Comparator group

Description:

evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks

Treatment:

Device: ultrasound elastography

evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts

Active Comparator group

Description:

revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values

Treatment:

Device: ultrasound elastography