Effect of oral dexamethasone for prevention of postembolization syndrome after hepatic conventional transarterial chemoembolization: A prospective randomized, double blinded, placebo controlled trial
Phase 2
- Conditions
- Postembolization syndrome after hepatic conventional transarterial chemoembolizationPostembolization syndrome
- Registration Number
- TCTR20210518001
- Lead Sponsor
- THE GASTROENTEROLOGICAL ASSOCIATION OF THAILAND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
1. Hepatocellular carcinoma
2. Child-Pugh score <= 7
3. Indication for treatment with TACE
Exclusion Criteria
1.Main portal vein thrombosis
2.SMV and IVC thrombosis
3.Hepatosystemic shunt
4.Tumor size > 50% of liver or > 10 cm
5.Bile duct obstruction
6.UGIH
7.Ascites
8.HR<50/min
9.TB>3mg/dl
10.ANC<1500
11.Platelet<80,000
12.INR>1.5
13.Cr>2
14.Uncontrolled heart disease
15.Active infection
16.HIV infection
17.Uncontrolled DM
18.Untreated HBV infection
19.Fever or nausea/vomiting
20.Steroid or NSAIDs use
21.Other malignancy within 3 years
22.Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy for prevention of postembolization syndrome 1 week Score by Southwest oncology group toxicity coding
- Secondary Outcome Measures
Name Time Method Quality of life 1 week EORTC QLQHCC18 and FACT-Hep questionaires