Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06336226
Other study ID # BB AVF one stage vs two stage
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information

Verified date April 2024
Source Assiut University
Contact Ahmed AM Abdelrasheed, Resident
Phone 01032735951
Email ahmeddawood2597@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Brachio basilic arterio venous fistula one stage versus two stage
Comparative study between one stage brachio basilic arterio venous fistula versus two stage

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Completed NCT03044496 - NIRS Measurement After SCP Block
Recruiting NCT03054623 - Hemodynamic Assessment of Distal Revascularization Interval Ligation N/A
Completed NCT05801549 - Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
Completed NCT04011072 - Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients N/A
Active, not recruiting NCT04376567 - Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas N/A
Completed NCT03242343 - VasQ External Support for Arteriovenous Fistula N/A
Recruiting NCT06091839 - Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis N/A
Enrolling by invitation NCT04381754 - Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
Enrolling by invitation NCT04054440 - Outpatient Office Based Endovascular Procedures
Completed NCT03988270 - Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy N/A
Completed NCT04925635 - Fistula Care and Mobile Health Applications in Hemodialysis Patients
Completed NCT04177901 - The Use of NIRS in Brachial Plexus Block N/A
Completed NCT04978155 - Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access
Completed NCT04222881 - End-to-side Versus Side-to-side Anastomosis With Distal Vein Ligation for Arteriovenous Fistula Creation
Recruiting NCT03853070 - Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Completed NCT04293614 - Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study
Recruiting NCT03731000 - PHIL® Embolic System Pediatric IDE N/A