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

NCT06997042 | Recruiting

• 1 other identifier: HCB/2025/0087
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemodialysis; vascular access; arteriovenous fistula; piggyback

Outcome Measures

Primary Outcomes (1)

• Percentage of clinical and echographic maduration of the fistula

  1 month and 12 months

Secondary Outcomes (1)

• Percentage juxta-anastomotic stenosis, thrombosis, reinterventions, fistula flow, maduration time, surgical time, wound complications

  1 and 12 months

Study Arms (2)

Terminolateral anastomosis

PLACEBO COMPARATOR

Patients assigned to this arm of intervention will have an anastomosis performed with the terminolateral anastomosis technique described in the protocol.

Procedure: Terminolateral anastomotic technique

Piggyback anastomosis

ACTIVE COMPARATOR

Patients assigned to this arm of intervention will be have an anastomosis performed with the piggyback anastomosis technique described in the protocol.

Procedure: Piggyback anastomotic technique

Interventions

Terminolateral anastomotic technique PROCEDURE

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

Terminolateral anastomosis

Piggyback anastomotic technique PROCEDURE

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

Piggyback anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 prior arteriovenous surgeries in the same or proximal location.
• Correct understanding of the study conditions and acceptance to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08018, Spain

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaspar Mestres, Medicine

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrián López, Medicine

CONTACT

+34 93 227 54 00; lopez74@clinic.cat

Gaspar Mestres, Medicine

CONTACT

+34 93 227 54 00; gmestres@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after publication, during 5 years.
• Access Criteria: Upon reasonable request, qualified researchers will be able to access to anonymized data of the study.

Locations

ES (1)