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

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

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.

Study Overview

• Status: Terminated
• Conditions: Brachiobasilic Arteriovenous Fistula
• Intervention / Treatment: Procedure: Transposition of the basilic vein and anastomosis with the brachial 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 265034
      • University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Procedure: Transposition of the basilic vein and anastomosis with the brachial vein; One-stage vs two-stage transposition of the basilic vein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Principal Investigator: Stavros Kakkos, MD, PhD, University of Patras

Publications and helpful links

General Publications

• El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8.
• 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.
• Wang J, Gong X, Chen H, Zhong W, Chen Y, Zhou Y, Zhang W, He Y, Lou M. Causative Classification of Ischemic Stroke by the Machine Learning Algorithm Random Forests. Front Aging Neurosci. 2022 Apr 15;14:788637. doi: 10.3389/fnagi.2022.788637. eCollection 2022.
• Kaneko F, Shindo K, Yoneta M, Okawada M, Akaboshi K, Liu M. A Case Series Clinical Trial of a Novel Approach Using Augmented Reality That Inspires Self-body Cognition in Patients With Stroke: Effects on Motor Function and Resting-State Brain Functional Connectivity. Front Syst Neurosci. 2019 Dec 17;13:76. doi: 10.3389/fnsys.2019.00076. eCollection 2019.
• Battaglia G, Alesi M, Tabacchi G, Palma A, Bellafiore M. The Development of Motor and Pre-literacy Skills by a Physical Education Program in Preschool Children: A Non-randomized Pilot Trial. Front Psychol. 2019 Jan 9;9:2694. doi: 10.3389/fpsyg.2018.02694. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Chronic renal failure; Basilic vein transposition fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2/20-4-10