A study to compare steroid versus N-acetyl cysteine to reduce complication after liver tumor directed vascular treatment

Dexamethasone versus N-acetylcysteine for the reduction of post-embolization syndrome following trans-arterial chemoembolization for Hepatocellular Carcinoma: a randomized controlled trial (DANCES trial- DexAmethasone versus NAC for Post-Embolization Syndrome) - DANCE

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063853

Enrollment

108

Registered

2024-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Dexamethasone: Dexamethasone will be given intravenously in a dose of 20 mg before the procedure on day 1 and will be continued in a dose of 8mg per day for two days post procedure Cont

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 (ALT) greater than 3X baseline value within 48 hrs after the procedureTimepoint: 48 hrs	—

Secondary

Measure	Time frame
The secondary outcomes will be the proportions of patients developing PTD in both groups. Any development of new or worsening ascites, encephalopathy, gastrointestinal bleeding and 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	—

Measure

Time frame

The secondary outcomes will be the proportions of patients developing PTD in both groups. Any development of new or worsening ascites, encephalopathy, gastrointestinal bleeding and 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

—

Countries

India

Contacts

Public ContactDr Anshuman

All India Institute of Medical Sciences

anshu27790@gmail.com8587935706

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026