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

NCT06997042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease Requiring Hemodialysis

Interventions

PROCEDURE

Terminolateral anastomotic technique

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

PROCEDURE

Piggyback anastomotic technique

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Gaspar Mestres, Medicine · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-10-01
Completion
2027-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997042 on ClinicalTrials.gov