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A randomized and prospective study about effects and safety of prophylactic dexamethasone on post transarterial chemoembolization syndrome

A randomized and prospective study about effects and safety of prophylactic dexamethasone on post transarterial chemoembolization syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0002277
Enrollment
88
Registered
2017-03-24
Start date
2015-08-17
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : In the dexamethasone group, 0.3 mg of intravenous ramosetron (a serotonin antagonist) and 12 mg of intravenous dexamethasone in 10 mL of normal saline was administered 30 minutes before TACE. I

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) age 18-80 years, (2) an Eastern Cooperative Oncology Group performance status of zero, (3) Child-Pugh Class A, (4) intermediate stage HCC (BCLC B) according to the BCLC staging classification, (5) treated with TACE with doxorubicin, (6) a serum creatinine level lower than 1.5 mg/dL.

Exclusion criteria

Exclusion criteria: (1) concurrent serious medical condition(s) such as underlying cardiac or renal disease, (2) other concurrent primary malignancy, (3) other chemotherapy, such as hepatic arterial infusion chemotherapy or systemic chemotherapy, (4) chronic hepatitis B patients who were not treated with antiviral therapy because steroids can induce viral reactivation in patients with chronic hepatitis B and who were not treated with antiviral therapy.

Design outcomes

Primary

MeasureTime frame
incidence of postembolization syndrome after TACE

Secondary

MeasureTime frame
Evaluation of nausea, vomiting, fever, abdominal pain, and ALT elevation after TACE;evaluation of safety and adverse effect

Countries

Korea, Republic of

Contacts

Public ContactHyun Yang

The Catholic University of Korea, Seoul St. Mary's Hospital

oneggu@naver.com+82-2-2258-2073

Outcome results

None listed

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