Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Oct 26, 2021; 9(30): 9059-9069
Published online Oct 26, 2021. doi: 10.12998/wjcc.v9.i30.9059
Single dose dexamethasone prophylaxis of postembolisation syndrome after chemoembolisation in hepatocellular carcinoma patient: A randomised, double-blind, placebo-controlled study
Panot Sainamthip, Chutcharn Kongphanich, Naiyarat Prasongsook, Sakkarin Chirapongsathorn
Panot Sainamthip, Department of Pharmacology, Chulalongkorn University, Bangkok 10330, Thailand
Chutcharn Kongphanich, Department of Radiology, Phramongkutklao College of Medicine, Bangkok 10400, Thailand
Naiyarat Prasongsook, Division of Medical Oncology, Department of Medicine, Phramongkutklao College of Medicine, Bangkok 10400, Thailand
Sakkarin Chirapongsathorn, Division of Gastroenterology and Hepatology, Department of Medicine, Phramongkutklao College of Medicine, Jatujak 10900, Thailand
Author contributions: Chirapongsathorn S and Sainamthip P had full access to all of the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis; Chirapongsathorn S, Sainamthip P and Kongphanich N contributed to the acquisition, analysis, or interpretation of data; Chirapongsathorn S contributed to the study concept and design; Chirapongsathorn S, Sainamthip P and Prasongsook N drafted the manuscript; Chirapongsathorn S and Prasongsook N contributed to the critical revision of the manuscript for important intellectual content; and Chirapongsathorn S supervised the study.
Institutional review board statement: Institutional Review Board of the Royal Thai Army Medical Department committee used World Medical Association: DELCARATION OF HELSINKI, GUIDELINE FOR GOOD CLINICAL PRACTICE: ICH Harmonised Tripartite Guideline, Council for International Organizations of Medical Sciences (CIOMS), CODE of FEDERAL REGULATIONS: Title 45 Public Welfare; Part 46 Protection of Human Subjects and The Belmont Report to regulate the ethical concern in publication Informed consent was obtained from all subjects, and all methods were conducted according to the relevant guidelines and regulations.
Clinical trial registration statement: The study was registered in the Thai Clinical Trials Registry (TCTR20170906004).
Informed consent statement: All subjects have been properly instructed and have consented to participate in this trial by signing the informed consent regulation provided by Institutional Review Board of the Royal Thai Army Medical Department committee. Informed consent was obtained by signature of all participants from all subjects to inform all the information about publication.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: The datasets used during the current study are available from the corresponding author on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised 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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sakkarin Chirapongsathorn, MD, MSc, Associate Professor, Division of Gastroenterology and Hepatology, Department of Medicine, Phramongkutklao College of Medicine, 315 Rajvithee, Jatujak 10900, Thailand. sakkarin.chi@pcm.ac.th
Received: July 4, 2021
Peer-review started: July 4, 2021
First decision: July 26, 2021
Revised: July 26, 2021
Accepted: September 10, 2021
Article in press: September 10, 2021
Published online: October 26, 2021
Processing time: 109 Days and 5.4 Hours
ARTICLE HIGHLIGHTS
Research background

Corticosteroids are used empyrically to prevent postembolisation syndrome (PES) after transcatheter arterial chemoembolisation (TACE).

Research motivation

Effects of corticosteroids administration before TACE on the prevention of PES have not been demonstrated in detail.

Research objectives

We conducted the present study to examine the utility and safety of steroid use in the prevention of PES following TACE.

Research methods

This study was a well-designed prospective randomized control trial answering the important clinical question in hepatocellular carcinoma patients undergo TACE.

Research results

The result of this study showed that single dose 8 milligrams of intravenous dexamethasone one hour before TACE was significantly reduce the incidence of PES in 48 h.

Research conclusions

We conclude that the administration of single dose of intravenous dexamethasone was useful for the prevention of adverse events after TACE in patients with hepatocellular carcinoma.

Research perspectives

Further examination is needed to confirm the utility and tolerability of dexamethasone for prevention of PES with respect to TACE in a large study trial.