JPRN-jRCTs032190083招募中未知
Efficacy of Irreversible electroporation (IRE) on patients with hepatocellular carcinoma who are not eligible for liver resection and radiofrequency ablation (RFA): a multicenter trial
Sugimoto Katsutoshi0 个研究点目标入组 45 人开始时间: 2019年8月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Male and female with older than or equal to 20-year-old
- •2)Patients who are pathologically proven or radiologically diagnosed hepatocellular carcinoma (HCC)
- •3)Patients with HCC who meet Milan criteria (one lesion smaller than 5 cm; alternatively, up to 3 lesions, each smaller than 3 cm)
- •4)Patients who are not eligible for liver resection and radiofrequency ablation
- •5)Presence or absence of pretreatment is not essential qualification; but it is necessary that at least more than 4 weeks has passed since previous treatment
- •6)Patients with Child-Pugh score less than or equal to 9
- •7)Patients with ECOG performance status of 0 to 2
- •8)Patients preserved adequate bone morrow, liver and kidney functions, as shown below:
- •White blood cell: >2,000 /mm3, and/or <10,000 /mm3
- •Platelet: >50,000 /mm3
- •Hemoglobin: >8.0 g/dL
- •Serum total bilirubin: <2.0 mg/dL
- •eGFR: >45 ml/min/1.73m2
- •BUN: <35 mg/dL
- •9)Patients who have obtained agreements for participation in writing
排除标准
- •1)Patients who have active double cancer (synchronous double cancer) or who have metachronous double cancer within five years disease duration: note that carcinoma in situ which is judged to be cure is not included
- •2)Patient who have diagnosed as myocardial infarction, unstable angina, cardiac failure, and arrhythmia with care within 6 months before registration
- •3)Patients who are difficult to be secured of safety percutaneous approach
- •4)Patients who use pacemakers
- •5)Patients who have iodine allergies, decline in renal function (eGFR<45ml/min/1.73m2), and cannot undertake contrast-enhanced CT for any reasons
- •6)Patients who are judged to be difficult to undergo this clinical trial due to psychiatric disease or psychological symptom
- •7)Patients who are in pregnancy or probable of pregnancy
- •8)Besides, patients who are judged as inappropriate for registration by doctor in charge
研究者
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