Clinical trial NCT06336226: Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage
Official title: Brachio Basilic Arterio Venous Fistula One Stage Versus Two Stage as a Hemodialysis Access
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arterio-venous Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative study between one stage brachio basilic arterio venous fistula versus two stage
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Haitham A Hasan, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Kh Sayed, Lecturer
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Wael A Abdelgawad, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.