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

University of Patras

Status: Terminated

Conditions: Brachiobasilic Arteriovenous Fistula

Treatments: Procedure: Transposition of the basilic vein and anastomosis with the brachial vein

Study type: Interventional

Funder types: Other

Identifiers

NCT01274117

2/20-4-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

One-stage transposition of the basilic vein

Placebo Comparator group

Description:

One-stage transposition of the basilic vein

Treatment:

Procedure: Transposition of the basilic vein and anastomosis with the brachial vein

Two-stage transposition of the basilic vein

Experimental group

Description:

Two-stage transposition of the basilic vein

Treatment:

Procedure: Transposition of the basilic vein and anastomosis with the brachial vein