RecruitingNot ApplicableNCT06997042

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

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


Sponsor

Hospital Clinic of Barcelona

Enrollment

130 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for creating an arteriovenous fistula — a connection between an artery and a vein in the arm used for dialysis — in patients with advanced kidney disease who need hemodialysis. It aims to find out which technique leads to better, longer-lasting access. **You may be eligible if...** - You are an adult over 18 with advanced chronic kidney disease (stage 5D) who needs or will soon need hemodialysis - You have undergone a pre-operative ultrasound confirming adequate vein and artery size for surgery - You are medically fit for the procedure - You do not have a kidney transplant scheduled within the next 60 days **You may NOT be eligible if...** - You are pregnant - Your expected survival is less than 1 year - You have already had arteriovenous surgeries at the same site - You have known or suspected clotting disorders or significant active infection - You have severe heart disease (NYHA Class III–IV) or a recent heart attack Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETerminolateral anastomotic technique

Suturing the vein and artery of the arteriovenous fistula with a terminolateral anastomotic suture.

PROCEDUREPiggyback anastomotic technique

Suturing the vein and artery of the arteriovenous fistula with a piggyback anastomotic technique.


Locations(1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

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NCT06997042


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