Trial Comparing One-stage With Two-stage Basilic Vein Transposition
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Purpose
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 | Intervention |
|---|---|
|
Brachiobasilic Arteriovenous Fistula |
Procedure: Transposition of the basilic vein and anastomosis with the brachial vein |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Maturation rate [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]Usage of the AVF (or clearance in case of pre-hemodialysis)
- Long term primary, primary assisted and secondary patency [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]Long term primary, primary assisted and secondary patency
- Complication rate [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]Hematoma, steal syndrome, venous hypertension
- Basilic vein size [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Basilic vein size on ultrasound
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2010 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Stavros K Kakkos, MD, PhD, MSc | +30-2613603406 | kakkos@upatras.gr |
| Contact: Ioannis A Tsolakis, MD, PhD, | +30-2613603360 | itsolak@upatras.gr |
| Greece | |
| University Hospital of Patras | Recruiting |
| Patras, Achaia, Greece, 265034 | |
| Contact: Stavros Kakkos kakkos@upatras.gr | |
| Principal Investigator: Stavros Kakkos, MD, PhD, MSc | |
More Information
Publications:
| Responsible Party: | Stavros Kakkos, Assistant Professor, Dept of Vascular Surgery, University Hospital of Patras |
| ClinicalTrials.gov Identifier: | NCT01274117 History of Changes |
| Other Study ID Numbers: | 2/20-4-10 |
| Study First Received: | January 10, 2011 |
| Last Updated: | January 10, 2011 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Patras:
|
Chronic renal failure Basilic vein transposition fistula |
Additional relevant MeSH terms:
|
Arteriovenous Fistula Fistula Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities |
Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on October 18, 2012
