A Randomized Double-blinded Placebo-controlled Trial of Prophylactic Rectal Indomethacin for Prevention of Post-embolization Syndrome in Patients with Hepatocellular Carcinoma

A randomized double blinded placebo controlled trial of prophylactic rectal indomethacin for prevention of postembolization syndrome in Patients with hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210209002

Enrollment

120

Registered

2021-02-09

Start date

2021-05-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Post-embolization syndrome Rectal indomethacin Post-embolization syndrome TACE Hepatocellular carcinoma Interleukin-6 Interleukin-13 TNF-alpha ICAM-1

Interventions

Rectal indomethacin,Identical placebo supposition

Placebo Comparator Drug,Placebo Comparator Drug

Rectal indomethacin,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with intermediate stage (B) HCC eligible for TACE according to the latest (2018) EASL Clinical Practice Guideline in Management of Hepatocellular Carcinom

Exclusion criteria

Exclusion criteria: Serum Cr > 1.4 mg/dl Recent GI bleeding within 4 weeks Allergy to NSAIDs or aspirin Concomittent use of oral NSAIDs, steroid within 1 week

Design outcomes

Primary

Measure	Time frame
Rate of post-embolization syndrome within 7 days observation	—

Secondary

Measure	Time frame
Length of stay until discharge IPD record,Inflammatory cytokines level at 48 hr and at day 7 Laboratory investigation,Factors associated with development of PES during admission Data collection	—

Countries

Thailand

Contacts

Public ContactKrittaya Mekritthikrai

Chulalongkorn University

Krittaya.deer@gmail.com0879703667

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026