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

NCT ID: NCT01274117

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-05-31

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.

Conditions

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Brachiobasilic Arteriovenous Fistula

Keywords

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Chronic renal failure Basilic vein transposition fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One-stage transposition of the basilic vein

One-stage transposition of the basilic vein

Group Type PLACEBO_COMPARATOR

Transposition of the basilic vein and anastomosis with the brachial vein

Intervention Type PROCEDURE

One-stage vs two-stage transposition of the basilic vein

Two-stage transposition of the basilic vein

Two-stage transposition of the basilic vein

Group Type EXPERIMENTAL

Transposition of the basilic vein and anastomosis with the brachial vein

Intervention Type PROCEDURE

One-stage vs two-stage transposition of the basilic vein

Interventions

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Transposition of the basilic vein and anastomosis with the brachial vein

One-stage vs two-stage transposition of the basilic vein

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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Stavros Kakkos

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stavros Kakkos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Patras

Locations

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University Hospital of Patras

Pátrai, Achaia, Greece

Site Status

Countries

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Greece

References

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

Reference Type BACKGROUND
PMID: 9754891 (View on PubMed)

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.

Reference Type RESULT
PMID: 25973421 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35493925 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31920571 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30687164 (View on PubMed)

Other Identifiers

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2/20-4-10

Identifier Type: -

Identifier Source: org_study_id