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

Not Applicable

Completed

• Conditions: May-Thurner Syndrome
• Interventions: Diagnostic Test: Duplex ultrasound

• Registration Number: NCT06180122
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-22
• Study Start: 2024-03-05
• Status Verified: 2024-05
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptomatic Group	Duplex ultrasound	Participants who are suffer from unexplained left leg swelling.
Asymptomatic Group	Duplex ultrasound	Participants who do not suffer from unexplained left leg swelling

Primary Outcome Measures

Name	Time	Method
Left common iliac vein diameter	6 months	The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.

Secondary Outcome Measures

Name	Time	Method
Inter-and intra-operator variation of the diameter measurement of the left common iliac vein	6 months	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.

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, Greater London, United Kingdom