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临床试验/TCTR20220412008
TCTR20220412008已完成3 期

Efficacy of Combine Dexamethasone and N-Acetylcysteine for prevent Post-embolization syndrome after Transarterial Chemoembolization in hepatocellular carcinoma (HCC)

avamindradhiraj University Research Fund0 个研究点目标入组 100 人开始时间: 2022年4月12日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
100

研究概览

简要总结

100 patients were enrolled 50 patients were randomly assigned to dexamethasone plus NAC and placebo were significantly lower developed PES in dexamethasone and NAC than placebo group (6 % VS 80 % P 0.001 ) and multivariate analysis DEXA and NAC is protective factor against PES with an OR of 0.04 ( P 0.001) Post-TACE liver decompensation was documented in 7 from 50 ( 14 % ) in control group

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • Eligible individuals were inpatients aged between 18 to 80 years with diagnosed early or intermediate state HCC base on Barcelona Clinical Liver Cancer (BCLC) without main portal vein invasion and extrahepatic metastasis and fit ( ECOG 0-1) for underwent TACE treatment. Criteria diagnosis of HCC was presence of histologically confirmed or radiologically diagnosed HCC (fulfilled criteria for lesions with typical imaging according to American Association for the study of Liver Disease (ASLD) Europian Association for the study of Liver (EASL) or Thai Association for the study of Liver (THASL).

排除标准

  • The exclusion criteria were as follow
  • 1.Decompensated Liver cirrhosis (child Pugh score more than 9)
  • 2. congestive heart failure and/or respiratory failure
  • 3. severe comorbid illness with expected life expectancy < 6 months ( e.g. end stage renal disease , poor control DM or HbA1C > 8.5, Uncontrolled HT (SBP > 180 mmHg or DBP > 120 mmHg)
  • 4. severe allergy or anaphylaxis/anaphylactoid to NAC or Drug interaction with nitroglycerine
  • 5. pregnancy
  • 6. History using of NSAID, Steroid, NAC with 21 days
  • 7. Main portal vein invasion
  • 8. refusal to participated in this study

研究者

发起方
avamindradhiraj University Research Fund

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