Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Serum total bilirubin on postoperative day 5
研究概览
简要总结
The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.
详细描述
High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.
This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.
This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;
- •Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;
- •Tumors located either in the left or right hemiliver;
- •Resection extent was a hemi-hepatectomy or less;
- •Informed consent.
排除标准
- •Having comorbidity that contraindicates surgery;
- •Participation in concurrent interventional trials with interference to this study;
- •Eligible for laparoscopic hepatectomy;
- •Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;
- •Lack of compliance for treatment or future follow-up.
结局指标
主要结局
Serum total bilirubin on postoperative day 5
时间窗: 5 days
Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
次要结局
- Requirement of blood transfusion(Entire operation duration)
- Hospital stay(Duration of hospital stay)
- Long-term survival(5 years after operation)
- Total hospital expenditure(Duration of hospital stay)
- Long-term oncologic outcomes(5 years after operation)
- Intraoperative blood loss(Entire operation duration)
- Operative time(Entire operation duration)
- Postoperative intensive-care unit (ICU) stay(Duration of stay in ICU)
- Postoperative morbi-mortality(an expected average of 12 days in hospital)
- Perioperative systemic inflammatory response(an expected average of 7 days)
研究者
Prof. Shichun Lu
Director, Department of Hepatobiliary Surgery
Chinese PLA General Hospital