A Large Series of Clinical and Imaging Investigation to Patients With Chronic Lower Limb Edema With Unclear Etiology

NCT ID: NCT01208623

Last Updated: 2010-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

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.

Conditions

Chronic Lower Limb Edema With Unclear Etiology

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

2D

2D digital venography images alone

No interventions assigned to this group

3D

3D rotational venography

No interventions assigned to this group

Combine

combined MDCT angiography/venography

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wan Fang Hospital Department of Radiology

Principal Investigators

Wing P. Chan

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University-Wan Fang Hospital

Locations

Taipei Medical University-Wan Fang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

99040

Identifier Type: OTHER

Identifier Source: secondary_id

NSC99-2314-B-038-024-

Identifier Type: -

Identifier Source: org_study_id