Hepatocellular carcinoma undergoing transarterial chemoembolization (TACE) Hepatocellular carcinoma (HCC), transarterial chemoembolisation (TACE), Dexamethasone, N-acetylcysteine, post-embolization syndrome
Conditions
Interventions
The dexamethasone protocol, received 5% dextrose 100 ml intravenous over 1 h followed by 500 ml intravenous over 4 h and 1,000 ml intravenous continuously until 48 hours post-TACE. Additionally receiv
Active Comparator Drug,Active Comparator Drug
Dexamethasone group,N-acetylcysteine group
Sponsors
Office of Research and Development, Phramongkutklao Hospital and Phramongkutklao College of Medicine (ORD PMK/PCM)
Internal medicine department, Phramongkutklao hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged more than 20 years old 2. Diagnosed with early or intermediate stage hepatocellular carcinoma (HCC) according to BCLC stage A or B. 3. Eastern Cooperative Oncology Group (ECOG) performance status scale 0 to 2.
Exclusion criteria
Exclusion criteria: 1.Patients with cirrhosis Child-Pugh class C (score more than 9) 2.active gastrointestinal bleeding 3.extrahepatic metastasis 4.hepatic encephalopathy based on the West Haven criteria 5.refractory ascites or portal vein thrombosis confirmed by findings from CT whole abdomen with contrast 6.serum total bilirubin level greater than 2 mg/dL 7. contraindications for arterial procedures 8.congestive heart failure and/or respiratory failure 9.history of allergic reactions to N-acetylcysteine or dexamethasone 10.severe comorbidities and a life expectancy of less than six months including poorly controlled diabetes with HbA1C level greater than 8%, end stage renal disease, uncontrolled hypertension (SBP more than 180 mmHg or DBP more than 120 mmHg) 11.pregnancy 12.patients with previous used non-steroidal anti-inflammatory drugs, steroids or N-acetylcysteine within 21 days before intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post embolization syndrome incidence 48 hours using temperature more than 38.5 degree Celsius and 3-fold higher alanine transaminase level from baseline within 48 h post embolization | — |
Secondary
| Measure | Time frame |
|---|---|
| The development of post-TACE liver decompensation 48 hours Defined as an increase in Child-Pugh score more than 2 points or newly developed decompensating events such as ascites, hepatic encephalopathy, or serum total bilirubin more than 2 mg/dL,Incidences of adverse reactions 48 hours Using Common Terminology Criteria for Adverse Events (CTCAE),Duration of admission days to week Number days of admission ,Progression-free survival 1 month Evaluated disease characteristics which confirm by CT/MRI abdomen | — |
Countries
Thailand
Contacts
Public ContactPadungkeat Karasin
Phramongkutklao hospital
Outcome results
None listed