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Trial Comparing One-stage With Two-stage Basilic Vein Transposition

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ClinicalTrials.gov Identifier: NCT01274117
Recruitment Status : Terminated (PRIMARY EFFICACY OUTCOME MEASURE (MATURATION) WAS SIGNIFICANT, IN FAVOR OF THE TW0-STAGE PROCEDURE)
First Posted : January 11, 2011
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Stavros Kakkos, University of Patras

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. A single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether.

The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.


Condition or disease Intervention/treatment Phase
Brachiobasilic Arteriovenous Fistula Procedure: Transposition of the basilic vein and anastomosis with the brachial vein Not Applicable

Detailed Description:

Arteriovenous fistulas (AVFs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. A single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage.

The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages
Study Start Date : December 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: One-stage transposition of the basilic vein
One-stage transposition of the basilic vein
 Procedure: Transposition of the basilic vein and anastomosis with the brachial vein
One-stage vs two-stage transposition of the basilic vein
Experimental: Two-stage transposition of the basilic vein
Two-stage transposition of the basilic vein
 Procedure: Transposition of the basilic vein and anastomosis with the brachial vein
One-stage vs two-stage transposition of the basilic vein


Outcome Measures
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Primary Outcome Measures :
  1. Maturation rate [ Time Frame: 6-10 weeks ]
    Usage of the AVF (or clearance in case of pre-hemodialysis)

  2. Long term primary, primary assisted and secondary patency [ Time Frame: 1-3 years ]
    Long term primary, primary assisted and secondary patency


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 1-3 years ]
    Hematoma, steal syndrome, venous hypertension

  2. Basilic vein size [ Time Frame: 4 weeks ]
    Basilic vein size on ultrasound


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic renal failure on hemodialysis
  • chronic renal failure with anticipated hemodialysis

Exclusion Criteria:

  • Patient unwillingness, not consenting
  • Cephalic vein options
  • Basilic vein less than 2.5 mm
  • Basilic vein with intrinsic lesions, unsuitable for use
Contacts and Locations
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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): NCT01274117


Locations
Greece
University Hospital of Patras
Patras, Achaia, Greece, 265034
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Stavros Kakkos, MD, PhD University of Patras
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Stavros Kakkos, Assistant Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01274117     History of Changes
Other Study ID Numbers: 2/20-4-10
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Stavros Kakkos, University of Patras:
Chronic renal failure
Basilic vein transposition fistula

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities