Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 21, 2025; 31(31): 109630
Published online Aug 21, 2025. doi: 10.3748/wjg.v31.i31.109630
Efficacy of N-acetylcysteine vs dexamethasone in preventing postembolization syndrome post-transarterial chemoembolization in hepatocellular carcinoma: A randomized controlled trial
Preeyamas Koonsiripaiboon, Witchakorn Ruamtawee, Nitipon Simasingha, Wasu Tanasoontrarat, Torpong Claimon, Supatsri Sethasine
Preeyamas Koonsiripaiboon, Supatsri Sethasine, Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit 10300, Bangkok, Thailand
Witchakorn Ruamtawee, Clinical Research Center, Research Facilitation Division, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit 10300, Bangkok, Thailand
Nitipon Simasingha, Division of Medicine, Udon Thani Hospital, Udon Thani 41000, Thailand
Wasu Tanasoontrarat, Torpong Claimon, Division of Intervention Radiology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit 10300, Bangkok, Thailand
Author contributions: Koonsiripaiboon P and Sethasine S conception, design, data collection; Simasingha N data collection; Tanasoontrarat W and Claimon T conducted TACE; Koonsiripiboon P, Ruamtawee W and Sethasine S statistical analysis and data interpretation; Koonsiripaiboon P and Sethasine S draft of the article; Ruamtawee W and Sethasine S critical revision of the manuscript; and all authors read and approved the final manuscript.
Supported by Faculty of Medicine Vajira Hospital, Navamindradhiraj University Research Fund, No. 1-67.
Institutional review board statement: The study was approved by the Institutional Review Board of the Faculty of Medicine, Vajira Hospital (COA 115/2567).
Clinical trial registration statement: The trial was prospectively registered at Thai Clinical Trial Registry, registration number (TCTR 20240816008).
Informed consent statement: All participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared according to the CONSORT 2010 statement.
Data sharing statement: The data used in the current study are available from the corresponding author upon reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Supatsri Sethasine, MD, Associate Professor, Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Road, Dusit 10300, Bangkok, Thailand. supatsri@nmu.ac.th
Received: May 19, 2025
Revised: June 18, 2025
Accepted: July 16, 2025
Published online: August 21, 2025
Processing time: 94 Days and 4.9 Hours
Abstract
BACKGROUND

Hepatocellular carcinoma (HCC) is a major health concern in Thailand, with most patients diagnosed at the intermediate stage. Transarterial chemoembolization (TACE) is the standard treatment; however, postembolization syndrome (PES) remains a common complication. Although both dexamethasone (DEXA) and N-acetylcysteine (NAC) have shown efficacy in reducing PES, no study has directly compared their effects.

AIM

To compare the incidence of PES between DEXA and NAC in intermediate-stage HCC patients undergoing conventional TACE (cTACE).

METHODS

A randomized, double-blind, controlled trial was conducted at two tertiary hospitals in Thailand from November 2024 to April 2025. Eligible HCC patients (aged 18-70 years) were randomized (1:1) to receive either NAC (150 mg/kg/hour loading dose, followed by 50 mg/kg over 4 hours, then 6.25 mg/kg/ hour for 48 hours post-cTACE) or DEXA (8 mg IV 1 hour before cTACE). cTACE was performed by blinded interventional radiologists. The primary outcome was PES occurrence within 48 hours, assessed using South West Oncology Group toxicity coding and the Common Terminology Criteria for Adverse Events. The secondary outcomes were post-cTACE liver decompensation and the dynamic changes in the albumin-bilirubin (ALBI) score.

RESULTS

A total of 56 intermediate-stage HCC patients were included (DEXA, n = 28; NAC, n = 28). Most had preserved liver function, with 92.9% classified as Child-Pugh A. The maximum tumor size was 6.2 cm, and 85.7% had multiple lesions. Additionally, 39 patients (69.6%) met the beyond up-to-7 criteria. Overall, 27 patients (48.2%) developed PES. After adjusting for confounding factors, the NAC group had a significantly lower incidence of PES than the DEXA group (32.1% vs 64.3%; adjusted odds ratio = 0.17, 95% confidence interval: 0.03-0.87, P = 0.033). Only two patients (3.6%) developed post-cTACE liver decompensation. Furthermore, 51.8% patients experienced worsening ALBI scores within 48 hours post-procedure; however, the rate of ALBI score worsening did not significantly differ between the groups.

CONCLUSION

Compared with DEXA, NAC significantly reduces the incidence of PES, regardless of its impact on liver function recovery. Therefore, NAC is a preferable option for reducing PES in Barcelona Clinic Liver Cancer-B stage HCC patients with preserved liver function.

Keywords: Dexamethasone; Hepatocellular carcinoma; N-acetylcysteine; Postembolization syndrome; Transarterial chemoembolization

Core Tip: N-acetylcysteine significantly reduces the incidence of postembolization syndrome compared with dexamethasone in patients with intermediate-stage hepatocellular carcinoma undergoing transarterial chemoembolization; however, both treatments have comparable effects on liver function recovery.