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

This study has been terminated.

(PRIMARY EFFICACY OUTCOME MEASURE (MATURATION) WAS SIGNIFICANT, IN FAVOR OF THE TW0-STAGE PROCEDURE)

Sponsor:

Information provided by (Responsible Party):

Stavros Kakkos, University of Patras

ClinicalTrials.gov Identifier:

NCT01274117

First received: January 10, 2011

Last updated: June 1, 2015

Last verified: June 2015

History of Changes

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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkes Weber syndrome capillary malformation-arteriovenous malformation syndrome

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	16
Study Start Date:	December 2010
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01274117

Locations


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

Sponsors and Collaborators

University of Patras

Investigators


Principal Investigator:	Stavros Kakkos, MD, PhD	University of Patras

More Information

Publications:

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.

El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8.


Responsible Party:	Stavros Kakkos, Assistant Professor, University 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:	June 1, 2015
Health Authority:	Greece: Ethics Committee

Keywords provided by University of Patras:


Chronic renal failure Basilic vein transposition fistula

Additional relevant MeSH terms:


Fistula Arteriovenous Fistula Pathological Conditions, Anatomical Arteriovenous Malformations Vascular Malformations	Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities

ClinicalTrials.gov processed this record on September 23, 2016

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