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

Phase 3

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

• Registration Number: TCTR20210209002
• Lead Sponsor: In process for Ratchadaphiseksomphot Endowment Fund submission

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-09
• Study Completion: 2022-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of post-embolization syndrome within 7 days observation

Secondary Outcome Measures

Name	Time	Method
ength 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