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临床试验/NCT02535117
NCT02535117Unknown4 期

Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Initial Partial Hepatectomy: A Multicenter Experience

Sun Yat-sen University0 个研究点目标入组 216 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
216
主要终点
Overall survival

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to the lack of donors Recurrence of tumor within the liver remnant is also common, with a reported 5-year recurrence rate of 50-70%, in patients who have undergone "curative" hepatectomy. Management of recurrent HCC is still urgent and several treatments have been developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a 5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with HCC recurrence due to the poor functional liver reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure more difficult and less safe. Recently, several studies reported that laparoscopic surgery for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. By far, no study has been performed to compare the efficacy and safety of laparoscopic surgery with RFA for treatment of recurrent HCC.

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

接受健康志愿者

入选标准

  • age 18-75 years;
  • recurrent HCC after curative partial hepatectomy;
  • no other treatment received except for partial hepatectomy;
  • a solitary recurrent HCC ≤ 5.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
  • no radiologic evidence of invasion into major portal/ hepatic vein branches ;
  • no extrahepatic metastases;
  • Child-pugh class A or B liver cirrhosis;
  • American Society of Anesthesiologists (ASA) score ≤ 3;
  • Eastern Co-operative Oncology Group performance (ECOG) status 0;

排除标准

  • coagulation disorders (prothrombin activity <40% or a platelet count of <80,000/mm3);
  • Child-Pugh class C liver cirrhosis;
  • history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
  • a history of a secondary malignancy;
  • active infection (except viral hepatitis);
  • severe dysfunction of the heart, kidney, or other organs

结局指标

主要结局

Overall survival

时间窗: 5 years

次要结局

  • Recurrence-free survival(5 years)
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(1 month)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen-Wei Peng

Ph.D.,M.D.

Sun Yat-sen University

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