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临床试验/NCT03262987
NCT03262987Unknown不适用

Color Doppler U/S vs MSCT Venography in the Diagnosis of May-Thurner Syndrome

Assiut University0 个研究点目标入组 25 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome

研究概览

简要总结

May-Thurner syndrome is the result of compression of the left common iliac vein between the right common iliac artery and overlying vertebrae.

In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner Syndrome in comparison to Direct CT Venography

详细描述

May-Thurner syndrome (MTS) is a venous compression syndrome in which the left common iliac vein is compressed between the lower lumbar spine and the right common iliac artery. While asymptomatic compression is very common, the process can lead to morbidity in selected individuals, most commonly deep venous thrombosis (DVT) and the sequelae thereof. Radiologists must recognize the diagnosis because of the unique management, which differs from DVT without iliac vein compression.

The most common clinical presentation is unilateral leg swelling due to acute DVT. It can also present as chronic venous insufficiency or chronic thrombosis with symptoms of venous hypertension and venous stasis namely claudication, pain, swelling, varicose veins and / or ulceration.

Conventional invasive catheter venography remains the gold standard for diagnosis,but the decision to undertake invasive venography should be made only after reviewing all available clinical data and alternative, less invasive imaging options have been exhausted.

When visualization of the common iliac veins is possible, MTS may be diagnosed with transabdominal color Doppler U/S.

MDCT with IV contrast is a fast, widely available examination for the diagnosis of MTS and accompanying complications .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • advanced chronic venous insufficiency submitted to clinical treatment for at least 1 year with no response.
  • Subject must be > 18 and < 80 years of age.
  • informed consent document before the planned procedure.
  • On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg.

排除标准

  • Previous venous stent implantation involving the study leg or inferior vena cava
  • Previous venovenous bypass surgery involving the study leg
  • Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication.
  • Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment).
  • Acute deep venous thrombosis involving either leg.
  • Known history of chronic total occlusion of the common femoral vein of the study leg.
  • Venous compression caused by tumor encasement.
  • Venous outflow obstruction caused by tumor thrombus.
  • Elevated baseline blood creatinine (value greater than the upper limit of the normal range).

结局指标

主要结局

Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome

时间窗: 1 year

Determine the sensitivity, specificity and accuracy of non invasive color doppler ultrasound, using direct and indirect ultrasonographic signs, in the diagnosis of May-Thurner Syndrome , considering direct CT Venography as the gold standard for this diagnosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Gamal Mokhtar

Resident Doctor

Assiut University

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