Efficacy of Combine Dexamethasone and N-Acetylcysteine for prevent Post-embolization syndrome after Transarterial Chemoembolization in hepatocellular carcinoma (HCC) ,A double-blind, Randomized controlled trial

Phase 3

Completed

• Conditions: To evaluate efficacy of Dexamethasone plus N-Acetylcysteine for prevention to develop Postembolization syndrome and Liver decompensation after TACE; Hepatocellular carcinoma , post embolization syndrome , TACE , Transarterial Chemoembolization , Dexamethasone , N-Acetylcysteine , Liver Decompensation

• Registration Number: TCTR20220412008
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-26
• Study Start: 2022-04-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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).

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
development of post-embolization syndrome 6 weeks Post-embolization syndrome , Defined base on base on South west oncology group (SWOG) toxic coding more than 2 point

Secondary Outcome Measures

Name	Time	Method
Development of post-TACE liver decompensation and duration of admission between to group 6 weeks Development of post-TACE liver decompensation define as 1. TB rising more than 2 2.new onset Ascite 3.new HE 4.CPS score rising more than 2 and duration of admission between admit to discharg