Prospective Randomized Evaluation of the Effect of Ligation of Venous Side Branches in Dialysis Arteriovenous Fistulas Presenting With Failure to Mature
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Fistula maturation rate
研究概览
简要总结
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.
详细描述
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is stenosis of the artery or vein. Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. The utility of ligating these veins to improve maturation of those failing AVFs is controversial. To evaluate this, 35 patients presenting for fistulograms for evaluation of AVFs with FTM, found to have side branch veins will be prospectively enrolled. After management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. Maturation rates for each group will be prospectively assessed. For patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.
排除标准
- •Age under 18 years
- •Pregnant women
- •Prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization)
- •Clinical evidence of infection associated with the AVF
- •Uncorrectable coagulopathy (International Normalized Radio >2.5, platelet count <50.000/μL)
- •Absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).
研究组 & 干预措施
Collateral vein ligation
Ligation of collateral veins under sonographic guidance
干预措施: Collateral vein ligation (Procedure)
Control
No collateral vein ligation.
结局指标
主要结局
Fistula maturation rate
时间窗: 8 weeks after randomization
Proportion of patients with usable arteriovenous fistula at the end of the study (being able to deliver the prescribed dialysis dose 75% of the sessions in the first 4 weeks of use via 2 needles)
次要结局
未报告次要终点
研究者
Zubin Irani
Instructor in Inteventional Radiology, Harvard Medical School
Massachusetts General Hospital