Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Percentage of clinical and echographic maduration of the fistula
研究概览
简要总结
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.
详细描述
Creation of Arteriovenous Fistulas for Hemodialysis: End-to-Side vs. Piggyback Anastomosis - A Randomized Clinical Trial
- Background and Rationale
Chronic Kidney Disease (CKD) affects an estimated 15.1% of the Spanish population and is a growing public health concern, especially due to its progression to advanced stages requiring renal replacement therapy (RRT). Hemodialysis is the most common RRT, and the quality of vascular access significantly influences outcomes in these patients.
Among vascular access options, arteriovenous fistulas (AVFs) are preferred over central venous catheters (CVCs) and arteriovenous grafts (AVGs), due to superior durability, fewer complications, and lower hospitalization rates. However, AVFs suffer from high early failure rates, with maturation failures occurring in up to 60% of cases.
Traditionally, the end-to-side (ETS) anastomosis is the gold standard for AVF creation. In recent years, an alternative technique called the Piggyback Straight Line Onlay Technique (pSLOT) has shown potential benefits, including improved hemodynamics, reduced stenosis, and lower rates of thrombosis and dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Terminolateral anastomosis
Patients assigned to this arm of intervention will have an anastomosis performed with the terminolateral anastomosis technique described in the protocol.
干预措施: Terminolateral anastomotic technique (Procedure)
Piggyback anastomosis
Patients assigned to this arm of intervention will be have an anastomosis performed with the piggyback anastomosis technique described in the protocol.
干预措施: Piggyback anastomotic technique (Procedure)
结局指标
主要结局
Percentage of clinical and echographic maduration of the fistula
时间窗: 1 month and 12 months
次要结局
- Percentage juxta-anastomotic stenosis, thrombosis, reinterventions, fistula flow, maduration time, surgical time, wound complications(1 and 12 months)
研究者
Adrián López
Medical Doctor
Hospital Clinic of Barcelona