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

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

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

Study Overview

• Status: Unknown
• Conditions: May-Thurner Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Omar Mokhtar, M.B.B.CH; Phone Number: +201094584576; Email: ogamalm2217@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All Patients suffering from advanced chronic venous insufficiency in the left leg.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed Koraim, Ass. Prof., Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Peripheral Vascular Diseases; Syndrome; May-Thurner Syndrome
• Other Study ID Numbers: May-Thurner Syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: to be shared when finished

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No