End-to-side versus Piggyback anastomosis to create arteriovenous fistulas for hemodialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with advanced CKD who are candidates for a new native arteriovenous fistula are randomly assigned during surgery to receive either the traditional end-to-side (ETS) anastomosis or the Piggyback Straight Line Onlay Technique (pSLOT). Procedures are performed under local anesthesia at a single center and patients undergo scheduled follow-up including ultrasound and clinical exams to monitor fistula maturation, patency, stenosis, thrombosis, and need for reintervention. Primary outcomes focus on AVF maturation and early failure rates, while secondary outcomes include complication rates, reintervention frequency, and dialysis catheter use. The randomized design aims to provide robust comparative data to determine whether pSLOT offers better long-term vascular access outcomes than ETS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years
* Able to meet protocol requirements, including follow-up.
* Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D).
* In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on standard clinical criteria).
* Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance procedures.
* Have a current ultrasound with preoperative venous and arterial mapping.
* Meet the anatomical requirements for AVF creation:

  * Wrist: artery \>2 mm, vein \>2 mm in diameter
  * Elbow: artery \>3 mm, vein \>3 mm in diameter
  * Absence of arterial calcification or occlusion, or other aberrant arterial anatomy.
  * Adequate arterial and venous patency.
  * Vein-to-skin distance \<5 mm.
* Candidate for creation of a native arteriovenous fistula for hemodialysis, either distal (radiocephalic) or proximal (humerocephalic or humerobasilic).
* No immediate transplant scheduled within the next 60 days (inclusion on the kidney transplant waiting list is not a contraindication for entry into the study, nor for the creation of an arteriovenous fistula).
* No prior arteriovenous surgeries in the same or proximal location.
* Correct understanding of the study conditions and acceptance to participate.

Exclusion Criteria:

* Pregnant women.
* Life expectancy \<1 year.
* Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and unusual (exotic) accesses.
* Known or suspected central venous stenosis/occlusion on the side of the planned access.
* Repair of previous arteriovenous accesses (proximal reanastomoses).
* Biological immunosuppression.
* History or evidence of serious systemic illness, including:

  * Cardiac disease (New York Heart Association functional class III or IV, as evidenced by the inability to lie still), myocardial infarction within 6 weeks prior to randomization, ventricular tachyarrhythmia requiring ongoing treatment, or unstable angina.

Suspected or documented hypercoagulable or hypocoagulable state or Clinically significant active infection (White blood count \> 15,000 cells/mm3) other than the use of a treated CVC.

* Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and efficacy of the study or poor compliance.
* Patient unwilling or unable to attend follow-up follow-ups.

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Gaspar Mestres, Medicine — Hospital Clinic of Barcelona
• Study coordinator: Adrián López, Medicine
• Email: lopez74@clinic.cat
• Phone: +34 93 227 54 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.