Actively Recruiting
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback Technique Randomized Clinical Trial
Led by Hospital Clinic of Barcelona · Updated on 2025-09-18
130
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for creating arteriovenous fistulas (AVFs), which are needed for hemodialysis in people with advanced chronic kidney disease (CKD). AVFs are preferred because they last longer and have fewer complications than other access types, but many fail to mature properly. This study evaluates the traditional End-to-Side (ETS) technique against a newer Piggyback Straight Line Onlay Technique (pSLOT) to see if pSLOT can reduce issues like narrowing, clotting, and failure. Participants are randomly assigned during surgery to receive either the ETS or pSLOT method under local or regional anesthesia. The trial involves two groups: one receiving the terminolateral anastomotic (ETS) technique and the other the piggyback anastomotic (pSLOT) technique. Follow-up visits occur at 1 month and 12 months after surgery to assess fistula maturation, blood flow, patency, and usability for dialysis. Remote follow-ups are allowed if needed. Participants undergo clinical exams and ultrasound mapping before surgery to ensure they meet anatomical requirements. During follow-ups, ultrasound and clinical assessments measure fistula development and function. Researchers will track outcomes like stenosis, thrombosis, reinterventions, blood flow, surgery and maturation times, and wound complications. The study requires informed consent, follows ethical standards, and keeps data confidential. Total participation spans at least 12 months with regular monitoring.
CONDITIONS
Brief 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 or older
- Advanced chronic kidney disease stage 4 or 5, including pre-dialysis or hemodialysis patients
- Suitable anatomy for native arteriovenous fistula creation (artery and vein diameter requirements met)
- No prior arteriovenous fistulas or vascular surgery in the planned access area
- Able to understand and accept study conditions and provide informed consent
- No kidney transplant scheduled within 60 days
- Able to meet protocol requirements including follow-up visits
- Current ultrasound mapping of arteries and veins available
- Candidate for distal or proximal native arteriovenous fistula creation
You will not qualify if you...
- Pregnant women
- Life expectancy less than 1 year
- Presence of arteriovenous prostheses, prior fistula repairs, or non-standard vascular accesses
- Known or suspected central venous stenosis or occlusion on the planned access side
- Previous vascular surgery repair on planned access
- Use of biological immunosuppression
- Serious systemic illnesses including severe cardiac disease or recent myocardial infarction
- Active significant infection or abnormal blood counts
- Conditions preventing safety or efficacy evaluation or poor treatment compliance
- Unwilling or unable to attend follow-up visits
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery to create an arteriovenous fistula using either the terminolateral anastomotic technique or the piggyback anastomotic technique.
1 surgical visit (in-person)
Duration - 12 months
Participants have follow-up visits for clinical and ultrasound assessments to evaluate fistula maturation, patency, and function.
2 visits (1 month and 12 months post-surgery, in-person, remote follow-up may be permitted)
Trial Site Locations
Total: 1 location
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08018
Actively Recruiting
Research Team
A
Adrián López, Medicine
G
Gaspar Mestres, Medicine
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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