Post-ablation syndrome and pain after ablation therapy for hepatocellular carcinoma: efficacy and safety of prophylactic dexamethasone

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022461

Enrollment

Unknown

Registered

2019-04-12

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-04-15

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

Conditions

Hepatocelluar carcinoma

Interventions

Study group:Intravenous injection of 4-6 mg dexamethasone at 90 minutes before ablation therapy

Control group:Intravenous injection of saline at 90 minutes before ablation therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Diagnosed as HCC by either histopathological biopsy or the current practice guideline of the American Association for the Study of Liver Diseases; 3. Chronic hepatitis B virus infection; 4. Child-Pugh Class A or B; 5. Eastern Cooperative Oncology Group score of 0 or 1; 6. Number of ablated tumors in a single ablation treatment =3; Total diameter of all ablated tumors in a single ablation treatment of 3-7 cm; 7. ALT50%.

Exclusion criteria

Exclusion criteria: 1. Presence of extrahepatic metastasis or vascular invasion; 2. History of other malignancies; 3. History of hormone allergy; 4. Presence of uncontrollable infenction; 5. Presence of grade 1 or higher fever, pain, nausea or vomiting; 6. Presence of HBV DNA at or above the sensitivity of detection in patients who did not receive nucleos(t)ide analogue treatment; 7. Use of any antiemetic, anodyne or antipyretic within 3 days; 8. Underwent any steroids treatment, systematic chemotherapy or immunological targeting therapy within 3 months; 9. Underwent gastroenterostomy within 3 months; 10. Presence of severe gastric mucosal lesion, such as gastric ulcer (For patients with sour regurgitation, belching, periodic upper abdominal pain, abdominal tenderness or underwent long-term NSAIDS treatment,gastroscope should be performed before inclusion in order to make accurate diagnosis.) 11. History of upper gastrointestinal hemorrhage; 12. Patients with disease of immune system; 13. Presence of uncontroable diabetes mellitus (HbA1c>8%); 14. Significant cardiopulmonary disease; 15. Renal insufficiency; 16. Concurrent severe diseases of other systems.

Design outcomes

Primary

Measure	Time frame
Incidence of pain;Incidence of post-ablation syndrome (fever, nausea, vomiting and general malaise);	—

Secondary

Measure	Time frame
Use of symptomatic medicine (antiemetic, anodyne or antipyretic);Adverse events;	—

Countries

China

Contacts

Public ContactLi Wei

Beijing Ditan Hospital, Capital Medical University

vision988@126.com+86 15811029005

Outcome results

None listed

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