Chronic Lower Limb Edema With Unclear Etiology Clinical Trial
Official title:
A Large Series of Clinical and Imaging Investigation to Patients With Chronic Lower Limb Edema With Unclear Etiology
| Verified date | September 2010 |
| Source | Taipei Medical University WanFang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Department of Health |
| Study type | Observational |
Patients with chronic lower limb edema commonly suffered from extremities edema, pain,
varicosities, venous stasis changes, and deep venous thrombosis. A common challenge for
primary care physicians is to determine the cause and find an effective treatment for leg
edema of unclear etiology. The aims of this project are to determine the cause of patients
with chronic lower limb edema with conventional digital venography, the clinical value of
role of 3D rotational venography or combined multidetector (MD)CT angiography and iliac
venography using direct iliac venography for contrast administration via bilateral femoral
catheterization (MDCT angiography/venography) with volume-rendering images supplementary to
2D digital venography in evaluation of patients with chronic lower limb edema.
This project is designed as retrospective cross-sectional study. Between April 2008 and Dec
2009, a total of approximately 300 patients with chronic lower limb edema who had had
bilateral iliac digital venography and surgery at our institution will be reviewed. All
patients underwent surgery by one senior vascular surgeon for lower limb conditions within
one month after the venographic examination. Patients who had incomplete clinical and
surgical records or incomplete images will be excluded. The surgical findings of the
presence, anatomical location, and size of the venous narrowing will assessed and described.
Stenosis was defined as luminal narrowing of 50% or more compared to the prestenotic or
poststenotic lumen.With use of surgical findings as a the standard, the investigators
calculated and compared the diagnostic accuracies, sensitivities, specificities, positive
predict values and negative predict values of 2D digital venography images alone, 3D
rotational venography, and combined MDCT angiography/venography with volume-rendering images
supplementary to 2D digital venography.
With this large series study, the investigators believe that the cause of chronic lower leg
edema in our patients' population will be clarified. The value of additional 3D rotational
venography, and combination MDCT angiography/venography with volume-rendering images will
lead to higher diagnostic performance and may provide a helpful tool for planning surgical
and endovascular treatment, which has not been reported before.
| Status | Active, not recruiting |
| Enrollment | 300 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients who had complete clinical and surgical records or incomplete images. Exclusion Criteria: - Patients who had incomplete clinical and surgical records or incomplete images. |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taipei Medical University-Wan Fang Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Taipei Medical University WanFang Hospital | National Science Council, Taiwan |
Taiwan,