Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage

Brachio Basilic Arterio Venous Fistula One Stage Versus Two Stage as a Hemodialysis Access

The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .

Study Overview

• Status: Not yet recruiting
• Conditions: Arterio-venous Fistula
• Intervention / Treatment: Procedure: Brachio basilic arterio venous fistula one stage versus two stage

Detailed Description

In the last two decades, there have been concerted efforts by the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI), and the Fistula First Breakthrough Initiative to decrease the use of prosthetic grafts and increase autogenous (native) arteriovenous fistula(AVF) creation for hemodialysis access. When considering vascular access for hemodialysis on the basis of patency, resistance to infection,and associated complications, Native AVF should be selected as the first choice whenever possible. If the cephalic vein in the upper arm is unusable for AVF construction, the basilic vein can be superficialized and anastomosed to the brachial artery at the elbow to form a brachiobasilic arteriovenous fistula (BB)AVF .

If a BB AVF is to be constructed,duplex ultrasound should be used to check the path and size of the basilic vein. It is also important to determine if an adequate length can be mobilized .

The BB fistulae can be formed in one stage or two stages. To date, limited and conflicting data exist regarding primary failure and the patency rates of one-stage and two-stage procedures. Each procedure has advantages and disadvantages Both one-stage and two-stage procedures have their advantages and disadvantages.

Which procedure results in improved outcomes remains unclear. However, the basic principle is to superficialize the basilic vein and make it amenable to needle puncture.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed AM Abdelrasheed, Resident; Phone Number: 01032735951; Email: ahmeddawood2597@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients with end-stage renal disease who had their BBAVFs created either by the one-stage or two- stage technique.
• Patients with brachial artery diameter more than 3 . mm by duplex ultrasound (DUS).
• Patients with triphasic brachial artery by DUS.
• Patients with basilic vein diameter more than 3 mm by DUS.
• Patients who were able to give informed consent.
• Requirements for intervention agreement between the patient and the surgeon.
• Availability of patients for all follow-up visits.

Exclusion Criteria:

• Patients who already had a suitable cephalic vein for arteriovenous fistula creation.
• Patients whose brachial artery diameter was less than 3 mm by DUS.
• Patients with brachial artery disease proved by DUS.
• Patients whose basilic vein diameter was less than mm by DUS.
• Patients with ischemic cardiomyopathy.
• Patients with central venous stenosis or occlusion evidenced by duplex scanning.
• Patients with flexion deformity or skin lesions at the site of the fistula or over the course of the vein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One stage group; The one-stage operation was performed under regional anesthesia. A 5-cm incision at the ante cubital fossa identifies the basilic vein. The incision was extended proximally, and the underlying deep fascia was opened. The basilic vein was mobilized up to its junction with the brachial vein. The median cutaneous nerve of the forearm was carefully dissected and preserved. After side branches were ligated, the basilic vein was tunnelled subcutaneously, with a Roberts' forceps maintaining its axial orientation.An end-to-side arteriovenous anastomosisto the brachial artery was performed	Procedure: Brachio basilic arterio venous fistula one stage versus two stage; Comparative study between one stage brachio basilic arterio venous fistula versus two stage
Active Comparator: two stage group; he first stage of the two-stage procedure was performed under local anesthesia by formation of the arteriovenous anastomosis with minimal disturbance of the basilic vein. After 4 to 6 weeks, a flow assessment of the AVF by duplex scanning was made to determine if revision of the anastomosis was necessary at the second stage. The second stage was performed under regional anesthesia. The entire length of the basilic vein was mobilized, a"subcutaneous flap" was created, and the vein was positioned anterolaterally. Usually, a further 2 weeks was required before the AVF can be used	Procedure: Brachio basilic arterio venous fistula one stage versus two stage; Comparative study between one stage brachio basilic arterio venous fistula versus two stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative study between one stage brachio basilic arterio venous fistula versus two stage	Measures were primary fistula failure rates and patency rates at specific checkpoints.	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Haitham A Hasan, Professor, Assiut University; Study Director: Ahmed Kh Sayed, Lecturer, Assiut University; Principal Investigator: Wael A Abdelgawad, Lecturer, Alazhar University

Publications and helpful links

General Publications

• Bashar K, Healy DA, Elsheikh S, Browne LD, Walsh MT, Clarke-Moloney M, Burke PE, Kavanagh EG, Walsh SR. One-stage vs. two-stage brachio-basilic arteriovenous fistula for dialysis access: a systematic review and a meta-analysis. PLoS One. 2015 Mar 9;10(3):e0120154. doi: 10.1371/journal.pone.0120154. eCollection 2015.
• Kakkos SK, Lampropoulos GC, Nikolakopoulos KM, Tsolakis IA, Papadoulas SI, Papachristou EC, Goumenos D, Lazarides MK. A Systematic Review and Meta-Analysis of Randomized Trials Comparing Two-Stage with One-Stage Brachio-Basilic Vein Fistulas. Vasc Specialist Int. 2018 Sep;34(3):51-60. doi: 10.5758/vsi.2018.34.3.51. Epub 2018 Sep 30.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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: BB AVF one stage vs two stage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No