A study to compare steroid versus N-acetyl cysteine to reduce complication after liver tumor directed vascular treatment
Phase 3
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2024/03/063853
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All consecutive patients presenting to the Liver Clinic of the Department of Gastroenterology
and Human Nutrition, with cirrhosis and HCC in BCLC stages A-C who are being considered for
TACE will be screened for inclusion and will be included after informed consent
Exclusion Criteria
1. Allergy to contrast media
2. Main portal vein tumor thrombosis (PVTT)-VP4
3. Extrahepatic disease extension of HCC
4. Child Turcotte Pugh score greater than 9
5. Renal failure
6. Those already on steroids for any other disease e.g. autoimmune hepatitis
7. Active bacterial infection at the time of randomization
8. Bilirubin greater than 3 mg per dL
9. Pregnancy
10. Age less than 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the proportion of patients developing PES in both groups. PES will be defined as presence of pain and or fever with an increase in the alanine aminotransferase <br/ ><br>(ALT) greater than 3X baseline value within 48 hrs after the procedureTimepoint: 48 hrs
- Secondary Outcome Measures
Name Time Method The secondary outcomes will be the proportions of patients developing PTD in both groups. <br/ ><br>Any development of new or worsening ascites, encephalopathy, gastrointestinal bleeding and <br/ ><br>increase in bilirubin by 2 mg per dL within one week of TACE. The proportion of patients with fever, nausea, vomiting, pain, ALT greater than 3X baseline will also be compared among both groups. Any side effects or complications related to the intervention used will also be reported.Timepoint: 7 days