The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter

Imperial College London

Status: Completed

Conditions: May-Thurner Syndrome

Treatments: Diagnostic Test: Duplex ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06180122

23CX8043

Details and patient eligibility

About

The goal of this feasibility/pilot study is to investigate whether or not vascular ultrasound can be used to aid the diagnosis of May Thurner Syndrome, in adult patients presenting to the vascular department with unexplained left leg swelling. The main research objective it aims to answer are:

• The diameter variation of the left common iliac vein based on posture, using duplex ultrasound.
• To determine inter- and intra-observer variation of the diameter measurement of the left common iliac vein using duplex ultrasound.

Participants will have an ultrasound scan performed on their abdomen by three different clinical vascular scientists, and will have each scan performed whilst lying supine on an examination couch and again when the couch is tilted to 45 degrees.

Researchers will compare the results of symptomatic patients to asymptomatic patients, to see if there is a difference in the diameter of the left common iliac vein between these two groups.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has the capacity to consent
• Participant is required to have a vascular ultrasound scan in the vascular ultrasound department
• Participant is 18 years of age or older at the start of the study.

Exclusion criteria

• Previous iliac vein intervention or treatment for iliac vein disease
• Previous diagnosis of iliac vein thrombus
• Pregnancy
• Unable to provide appropriate informed consent
• The participant does not require a vascular ultrasound as part of their routine care
• Under 18 years of age at the start of the study

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Symptomatic Group

Other group

Description:

Participants who are suffer from unexplained left leg swelling.

Treatment:

Diagnostic Test: Duplex ultrasound

Asymptomatic Group

Other group

Description:

Participants who do not suffer from unexplained left leg swelling

Treatment:

Diagnostic Test: Duplex ultrasound