Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- X-ray exposure duration
研究概览
简要总结
The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.
详细描述
Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.
PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3).
- •the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR < 1.7, no ascites, no encephalopathy).
- •Eligible for both femoral and radial puncture.
排除标准
- •Patients referred for embolization as treatment of traumatic splenic injury.
- •Patients lost during follow-up.
研究组 & 干预措施
femoral puncture
Under local anaesthesia, the femoral artery was punctured and 6F sheath was inserted. Splenic artery was catheterized using 4- or 5-F catheters (Cobra C2 cat or Simmons II catheter Imager-Boston Scientific Natick, Massachusetts). Embolization was done using Embospheres (Biosphere Medical, Rockland, MA) 700-900 μ in diameter.
干预措施: partial splenic artery embolization (Procedure)
Radial puncture
The left radial artery was preferred due to shorter distance from the left wrist to the splenic artery in comparison to the right wrist; also the left radial access theoretically decreases the risk of cerebral emboli. Under local anaesthesia and ultrasound guidance, the radial artery was punctured and 5- or 6-F sheath was introduced. After sheath insertion, the radial cocktail (2.5 mg of verapamil, 100 μg of nitroglycerin, and 5,000 units of heparin) was injected through the sheath over one minute after dilution with 20 ml of blood to decrease the discomfort during injection.
干预措施: partial splenic artery embolization (Procedure)
结局指标
主要结局
X-ray exposure duration
时间窗: Immediately after the procedure is complete
Duration of flouroscopy exposure during the procedure
Procedural time
时间窗: Immediately after the procedure is complete
The time interval from starting the anaethesia till completion of the procedure
Average number of punctures
时间窗: Immediately after the procedure is complete
Number of arterial punctures required to complete the procedure
Technical Success of the Procedure
时间窗: Immediately after the procedure is complete
The achievement of a single puncture allowing access to splenic artery without periprocedural complications.
Length of hospital stay
时间窗: 7 days
Number of days that the patient will spend in the hospital after the procedure.
Complications at access site
时间窗: 30 days
Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.
次要结局
- Procedural complications(30 days)
研究者
Mohamed M.A. Zaitoun
Associate Professor
Zagazig University