Clinical trial NCT01274117: Trial Comparing One-stage With Two-stage Basilic Vein Transposition
Official title: Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brachiobasilic Arteriovenous Fistula
Keywords: Chronic renal failure
Basilic vein transposition fistula
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Maturation rate
timeFrame: 6-10 weeks
measure: Long term primary, primary assisted and secondary patency
timeFrame: 1-3 years
Secondary outcomes:
measure: Complication rate
timeFrame: 1-3 years
measure: Basilic vein size
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University of Patras
name: Stavros Kakkos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8.
citation: Kakkos SK, Tsolakis IA, Papadoulas SI, Lampropoulos GC, Papachristou EE, Christeas NC, Goumenos D, Lazarides MK. Randomized controlled trial comparing primary and staged basilic vein transposition. Front Surg. 2015 Apr 29;2:14. doi: 10.3389/fsurg.2015.00014. eCollection 2015.
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