A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Primary unassited patency
研究概览
简要总结
A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.
详细描述
The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years;
- •Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
- •Brachial artery diameter ≥ 2 mm
排除标准
- •Stenosis or thrombosis present in the draining vein;
- •A history of peripheral ischemia in upper extremities;
- •Active local or systemic infections;
- •Inability to consent for the procedure;
- •Patients with previous dysfunctional forearm fistula.
研究组 & 干预措施
mNT-BBAVF
Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access
干预措施: mNT-BBAVF (Procedure)
BCAVF
Patients in CKD stage 4-5 without previous dysfunctional fistula access
干预措施: BCAVF (Procedure)
结局指标
主要结局
Primary unassited patency
时间窗: 12 months
The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.
次要结局
- Short-term complications(1 month)
- Cumulative patency(12 month)
- Long-term complications(12 months)
- Calculated blood flow volumes of the corresponding fistula segments(12 months)
- Diameters of the veins and arteries in the corresponding arm(12 months)
- Blood flow velocities of the veins and arteries in the corresponding arm.(12 months)
研究者
Ai Peng
Director of the department of Nephrology
Shanghai 10th People's Hospital