End-to-side versus Piggyback anastomosis to create arteriovenous fistulas for hemodialysis
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback. Randomized Clinical Trial
This trial will test whether the piggyback (pSLOT) or the traditional end-to-side surgical technique produces more reliable arteriovenous fistulas for adults with advanced chronic kidney disease who need hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06997042 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with stage 4–5 CKD who are candidates for a new native AVF, have suitable vessel anatomy on preoperative ultrasound, and can tolerate surgery and follow-up are ideal participants.
Not a fit: Patients who are not candidates for native AVF (for example due to small or calcified vessels, central venous occlusion, or existing functioning access) are unlikely to benefit from this trial.
Why it matters
Potential benefit: If pSLOT proves superior, patients could have higher rates of usable AVFs, fewer complications and reoperations, and reduced reliance on temporary dialysis catheters.
How similar studies have performed: Small retrospective and prospective reports suggest pSLOT may reduce stenosis and thrombosis, but no large randomized trial has yet confirmed these findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Barcelona, Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.