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The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter
NA trial testing Duplex ultrasound in May-Thurner Syndrome in 40 participants. Completed in 21 May 2024.
| Lead sponsor | Imperial College London |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 40 |
| Start date | 5 March 2024 |
| Primary completion | 21 May 2024 |
| Estimated completion | 21 May 2024 |
| Sites | 1 location across United Kingdom |
Imperial College London
18 and older, any sex, with May-Thurner Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.
| Group | Value | 95% CI |
|---|---|---|
| Symptomatic Group | 7.5 | ± 2.9 |
| Asymptomatic Group | 7.7 | ± 2.3 |
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. Three different scientists took three measurements each of the common iliac vein. The results from the three scientists were compared to determine inter-operator variation, and the results from one scientist each were compared to determine intra-operator variation.
| Group | Value | 95% CI |
|---|---|---|
| Interoperator Variability | 0.67 | 0.60 – 0.72 |
| Intraoperator Variability | 0.92 | 0.90 – 0.93 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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