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

NCT ID: NCT03262987

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-12-30

Brief 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

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.

Conditions

May-Thurner Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Gamal Mokhtar

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Koraim, Ass. Prof.

Role: STUDY_CHAIR

Assiut university, Egypt

Central Contacts

Omar Mokhtar, M.B.B.CH

Role: CONTACT

ogamalm2217@gmail.com

+201094584576

Other Identifiers

May-Thurner Syndrome

Identifier Type: -

Identifier Source: org_study_id