Actively Recruiting
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
Led by Hospital Clinic of Barcelona · Updated on 2025-09-18
130
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to compare two surgical techniques used to create arteriovenous fistulas (AVFs), which are necessary for hemodialysis in patients with advanced chronic kidney disease (CKD). AVFs are preferred over other forms of vascular access because they last longer and have fewer complications. However, many AVFs fail to mature properly, making them unusable for dialysis. The two techniques being studied are the traditional End-to-Side (ETS) method and a newer technique called Piggyback Straight Line Onlay Technique (pSLOT). Early studies suggest that pSLOT may reduce complications like narrowing (stenosis), clotting (thrombosis), and failure of the AVF, but more robust data from randomized clinical trials is needed. Patients aged 18 or older with stage 4 or 5 CKD, who are eligible for a new AVF and meet health criteria, may participate. During the operation, participants are randomly assigned to receive either the ETS or pSLOT technique. The procedure is done under local or regional anesthesia. Follow-up appointments are scheduled at 1 and 12 months to assess fistula maturation, blood flow, and whether it can be successfully used for dialysis. Remote follow-ups are allowed if needed. Participation is voluntary, requires informed consent, and all data is kept strictly confidential. The study follows national and international ethical standards and has been approved by an ethics committee.
CONDITIONS
Official Title
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Able to follow the study protocol and attend follow-ups
- Have advanced chronic kidney disease stage 5D or stage 5 anticipating dialysis within 6 months
- Medically able to undergo surgery and AVF maintenance
- Have recent ultrasound mapping of veins and arteries
- Meet anatomical criteria for AVF creation (artery >2 mm at wrist or >3 mm at elbow; vein >2 mm at wrist or >3 mm at elbow; vein-to-skin distance <5 mm; no arterial calcification or occlusion)
- Candidate for native arteriovenous fistula creation (distal or proximal)
- No kidney transplant scheduled within 60 days
- No previous AVF or vascular surgery in the same or proximal site
- Understand and agree to participate in the study
You will not qualify if you...
- Pregnant women
- Life expectancy less than 1 year
- Non-native fistulas, previous AVF repairs, lower extremity or unusual accesses
- Known or suspected central venous stenosis or occlusion on planned access side
- Repair of previous AV accesses (proximal reanastomoses)
- Use of biological immunosuppression
- Serious systemic illness including severe cardiac disease (NYHA class III or IV or recent heart attack)
- Active significant infection (white blood count > 15,000 cells/mm3) except treated central venous catheter
- Known blood clotting disorders
- Any condition preventing proper safety and efficacy evaluation or poor compliance
- Unwilling or unable to attend follow-up visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08018
Actively Recruiting
Research Team
A
Adrián López, Medicine
CONTACT
G
Gaspar Mestres, Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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