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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages

Conditions
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Brachiobasilic Arteriovenous Fistula

Intervention / Treatment
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* Procedure: Transposition of the basilic vein and anastomosis with the brachial vein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: One-stage transposition of the basilic vein<br>One-stage transposition of the basilic vein | Procedure: Transposition of the basilic vein and anastomosis with the brachial vein<br>* One-stage vs two-stage transposition of the basilic vein<br>|
| Experimental: Two-stage transposition of the basilic vein<br>Two-stage transposition of the basilic vein | Procedure: Transposition of the basilic vein and anastomosis with the brachial vein<br>* One-stage vs two-stage transposition of the basilic vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation rate | Usage of the AVF (or clearance in case of pre-hemodialysis) | 6-10 weeks | 
| Long term primary, primary assisted and secondary patency | Long term primary, primary assisted and secondary patency | 1-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Hematoma, steal syndrome, venous hypertension | 1-3 years | 
| Basilic vein size | Basilic vein size on ultrasound | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic renal failure, Basilic vein transposition fistula