Clinical Trial

Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-21; most recent amendment 2025-09-12.
Status change: Not Yet Recruiting → Recruiting 2025-09-12
Trial Details
NCT Number NCT06997042
Lead Sponsor Hospital Clinic of Barcelona
Conditions Chronic Kidney Disease Requiring Hemodialysis
Enrollment 130 participants
Start Date 2025-05-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-18