Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative surgical complications
研究概览
简要总结
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.
The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.
The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.
Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.
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
- •Child's A or B cirrhosis
排除标准
- •Informed consent not available
- •Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
- •Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation
- •Anticipation of portal vein resection
- •Emergency hepatectomy
- •Ruptured HCC
- •Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
- •Anticipation of concomitant bowel or bile duct resection
结局指标
主要结局
Post-operative surgical complications
时间窗: 1 month
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
次要结局
- Other post-operative complications(1 month)
- Survival(5 year)
- Recurrence rate of hepatocellular carcinoma(5 year)
研究者
Cheung Yue Sun
Clinical Assistant Professor (honorary)
Chinese University of Hong Kong