Status:
UNKNOWN
Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
N-acetylcysteine (NAC), a glutathione precursor and potent antioxidant, is known as a liver protector. As a steroid preparation, dexamethasone is known to have efficient anti-inflammation and immunosu...
Detailed Description
Aim \& Objectives Hypothesis: The combination of dexamethasone with NAC is superior to NAC alone in prevention of PES among patients who undergo TACE in HCC as both medications work differently to pre...
Eligibility Criteria
Inclusion
- All patients undergoing TACE procedure
- Valid Consent
- Age 18-65 years
Exclusion
- Child Pugh C, Child Pugh B \> 8
- HCC patients with a curative therapy (Ablation, Resection or LT)
- ECOG Performance Status 3-4
- Pregnancy
- History of allergic reaction from NAC
- significant cardiopulmonary disease
- UGI bleed within last 28 days
- Recent surgery within last 28 days
- Documented febrile illness in last 1 weeks
- Uncontrolled Diabetes (FBS \> 200, HBA1C \> 8)
- Uncontrolled Hypertension (BP \> 160/100)
- Structural kidney disease with eGFR \< 60 ml/min
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06039280
Start Date
September 15 2023
End Date
July 31 2024
Last Update
September 15 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070