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

May-Thurner Syndrome Clinical Trial

Official title:

The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein (CIV) Diameter, to Aid and Improve the Diagnosis of May Thurner Syndrome (MTS) in Patients Presenting With Unexplained Left Leg Swelling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06180122
• Other study ID #: 23CX8043
• Status: Completed
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: May 21, 2024

Study information

• Verified date: May 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 21, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• May-Thurner Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Duplex ultrasound
Vascular ultrasound scan of the left common iliac vein

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left common iliac vein diameter	The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.	6 months
Secondary	Inter-and intra-operator variation of the diameter measurement of the left common iliac vein	The inter- and intra-operator variation of the diameter measurement of the left common iliac vein using duplex ultrasound, in adults referred to the vascular ultrasound department.	6 months