NCT03082378Unknown不适用
Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.
In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •absence of ascites or the depth of ascites on US detection less than 4 cm;
- •a normal serum total bilirubin level or less than 60 µmol/L;
- •a normal albumin level or not less than 30 g/L;
- •for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- •for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
排除标准
- •clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
- •severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
- •high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
- •acute or active inflammatory and infectious lesions at any organ
- •acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
- •relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.
结局指标
主要结局
survival
时间窗: 3 years
Percentage of participants who survived up to end time point as assessed by Kaplan-Meier
次要结局
- intra-hepatic metastasis(3 years)
- extra-hepatic metastasis(3 years)
- local tumor progression(3 years)
- complication(3 years)
研究者
Yu Jie
Professor
Chinese PLA General Hospital
研究点 (1)
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