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临床试验/NCT05104086
NCT05104086Unknown不适用

Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts

Mansoura University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年12月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
33
试验地点
2
主要终点
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

盲法说明

Single investigator

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient suspected to have endometrioma or hemorrhagic ovarian cysts.

排除标准

  • 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

结局指标

主要结局

evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts

时间窗: 4 weeks

the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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