Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 7, 2023; 29(5): 890-903
Published online Feb 7, 2023. doi: 10.3748/wjg.v29.i5.890
Efficacy of dexamethasone and N-acetylcysteine combination in preventing post-embolization syndrome after transarterial chemoembolization in hepatocellular carcinoma
Nitipon Simasingha, Wasu Tanasoontrarat, Torpong Claimon, Supatsri Sethasine
Nitipon Simasingha, Supatsri Sethasine, Department of Internal Medicine, Navamindradhiraj University, Bangkok 10300, Thailand
Wasu Tanasoontrarat, Torpong Claimon, Department of Radiology, Navamindradhiraj University, Bangkok 10300, Thailand
Author contributions: Simasingha N and Sethasine S contributed to the conception and design of the study, data collection, and statistical analysis, and data interpretation; Tanasoontrarat W and Claimon T conducted TACE; Sethasine S contributed to drafting of the article and critical revision of the manuscript; and all authors read and approved the final manuscript.
Supported by the Navamindradhiraj University Research Fund and the Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 93/2564.
Institutional review board statement: The study was approved by the Institutional Review Board of the Faculty of Medicine, Vajira Hospital (COA 051/2564).
Clinical trial registration statement: The trial was registered at Thai Clinical Trial Registry, registration number TCTR20220412008.
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.
Data sharing statement: The data used in the current study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared according to the CONSORT 2010 statement.
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, Chief Doctor, Department of Internal Medicine, Navamindradhiraj University, Vajira Hospital Dusit Thailand, Bangkok 10300, Thailand. supatsri@nmu.ac.th
Received: October 24, 2022
Peer-review started: October 24, 2022
First decision: December 12, 2022
Revised: December 17, 2022
Accepted: January 16, 2023
Article in press: January 16, 2023
Published online: February 7, 2023
Abstract
BACKGROUND

Conventional transarterial chemoembolization (cTACE) is the current standard treatment for intermediate-stage hepatocellular carcinoma (HCC). Post-embolization syndrome (PES) is complex clinical syndrome that presents as fever, abdominal pain, nausea, and vomiting. Either dexamethasone (DEXA) or N-acetylcysteine (NAC) is used to prevent PES; however, the synergistic effect of their combined therapy for preventing PES and liver decompensation has not been determined.

AIM

To evaluate the efficacy of DEXA and NAC combination in preventing PES and liver decompensation after cTACE.

METHODS

Patients with Barcelona Clinic Liver Cancer stage A or B HCC who were scheduled for TACE were prospectively enrolled. All patients were randomly stratified to receive NAC and DEXA or placebo. The dual therapy (NAC + DEXA) group received intravenous administration of 10 mg DEXA every 12 h, NAC 24 h prior to cTACE (150 mg/kg/h for 1 h followed by 12.5 mg/kg/h for 4 h), and a continuous infusion of 6.25 mg/h NAC plus 4 mg DEXA every 12 h for 48 h after cTACE. The placebo group received an infusion of 5% glucose solution until 48 h after procedure. PES was defined by South West Oncology Group toxicity code grading of more than 2 that was calculated using incidence of fever, nausea, vomiting, and pain.

RESULTS

One-hundred patients were enrolled with 50 patients in each group. Incidence of PES was significantly lower in the NAC + DEXA group compared with in the placebo group (6% vs 80%; P < 0.001). Multivariate analysis showed that the dual treatment is a protective strategic therapy against PES development [odds ratio (OR) = 0.04; 95% confidence interval (CI): 0.01-0.20; P < 0.001). Seven (14%) patients in the placebo group, but none in the NAC + DEXA group, developed post-TACE liver decompensation. A dynamic change in Albumin-Bilirubin score of more than 0.5 point was found to be a risk factor for post-TACE liver decompensation (OR = 42.77; 95%CI: 1.01-1810; P = 0.049).

CONCLUSION

Intravenous NAC + DEXA administration ameliorated the occurrence of PES event after cTACE in patients with intermediate-stage HCC.

Keywords: Hepatocellular carcinoma, Post-embolization syndrome, Transarterial chemoembolization, Liver decompensation

Core Tip: Conventional transarterial chemoembolization (TACE) is the current standard treatment for intermediate-stage hepatocellular carcinoma (HCC). A combination of N-acetylcysteine and dexamethasone ameliorated the occurrence of post-embolization syndrome event after TACE in patients with intermediate-stage HCC. A dynamic change in Albumin-Bilirubin score of more than 0.5 point was found to be a risk factor for post-TACE liver decompensation.