A RCT Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .
详细描述
Background & Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77%~100%. Laparoscopic repeat liver resection (LRLR) has been shown in small retrospective studies to be a safe and effective treatment for recurrent hepatocellular carcinoma (rHCC) in selected patients, and radiofrequency ablation (RFA) has been increasingly performed for treating recurrent tumors involving the liver after hepatectomy. The aim of this study was to compare the short-term and long-term outcome of laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) in the treatment of rHCC.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender,18 to 70 years old;
- •Preoperative diagnosis of recurrent HCC clear,liver resection was done previously;
- •No active hepatitis and decompensated cirrhosis;
- •Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
- •No tumor rupture or bleeding;
- •Child-Pugh class A or B grade,ICG-R15 <20%;
- •No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds;
- •After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
- •Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts;
- •Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
- •Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.
排除标准
- •Opposite of the above inclusion criteria;
- •Severe upper abdominal adhesions;
- •Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
- •Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up;
- •Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.
研究组 & 干预措施
Laparoscopic Hepatectomy
Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.
干预措施: Laparoscopic Hepatectomy (Procedure)
Radiofrequency Ablation
With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .
干预措施: Radiofrequency Ablation (Procedure)
结局指标
主要结局
Survival rate
时间窗: 5 years
follow-up after the surgery every 3 months, to understand statistics 5-year survival.
次要结局
- intraoperative parameters(during the operation)
研究者
Shuguo Zheng, MD
Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Southwest Hospital, China