- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208623
A Large Series of Clinical and Imaging Investigation to Patients With Chronic Lower Limb Edema With Unclear Etiology
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.
Study Overview
Status
Detailed Description
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, we 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, we 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Taipei Medical University-Wan Fang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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2D
2D digital venography images alone
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3D
3D rotational venography
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Combine
combined MDCT angiography/venography
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wing P. Chan, Taipei Medical University-Wan Fang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSC99-2314-B-038-024-
- 99040 (WF IRB)
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