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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208623
First Posted: September 24, 2010
Last Update Posted: September 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose

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.


Condition
Chronic Lower Limb Edema With Unclear Etiology

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Large Series of Clinical and Imaging Investigation to Patients With Chronic Lower Limb Edema With Unclear Etiology

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
2D
2D digital venography images alone
3D
3D rotational venography
Combine
combined MDCT angiography/venography

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208623


Locations
Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Wing P. Chan Taipei Medical University-Wan Fang Hospital
  More Information

Responsible Party: Wing P. Chan, Wan Fang Hospital Department of Radiology
ClinicalTrials.gov Identifier: NCT01208623     History of Changes
Other Study ID Numbers: NSC99-2314-B-038-024-
99040 ( Other Identifier: WF IRB )
First Submitted: September 20, 2010
First Posted: September 24, 2010
Last Update Posted: September 24, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Edema
Signs and Symptoms