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

May-Thurner Syndrome Clinical Trial

— USvsCTV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03262987
• Other study ID #: May-Thurner Syndrome
• Status: Not yet recruiting
• Phase: N/A
• First received: August 24, 2017
• Last updated: August 24, 2017
• Start date: October 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Omar Mokhtar, M.B.B.CH
• Phone: +201094584576
• Email: ogamalm2217[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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 .

Magnetic resonance imaging (MRI) with MR venography is an attractive modality for the diagnosis, However, MRI is expensive, time consuming, has more limited availability than computed tomography (CT) and ultrasound, and may be impossible in select patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 30, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• May-Thurner Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome	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.	1 year