Sainamthip P, Kongphanich C, Prasongsook N, Chirapongsathorn S. Single dose dexamethasone prophylaxis of postembolisation syndrome after chemoembolisation in hepatocellular carcinoma patient: A randomised, double-blind, placebo-controlled study. World J Clin Cases 2021; 9(30): 9059-9069 [PMID: 34786388 DOI: 10.12998/wjcc.v9.i30.9059]
Corresponding Author of This Article
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
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Gastroenterology & Hepatology
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Clinical Trials Study
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Sainamthip P, Kongphanich C, Prasongsook N, Chirapongsathorn S. Single dose dexamethasone prophylaxis of postembolisation syndrome after chemoembolisation in hepatocellular carcinoma patient: A randomised, double-blind, placebo-controlled study. World J Clin Cases 2021; 9(30): 9059-9069 [PMID: 34786388 DOI: 10.12998/wjcc.v9.i30.9059]
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, 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.
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
Abstract
BACKGROUND
Even in the immuno-oncology era, transcatheter arterial chemoembolisation (TACE) is the most effective way to treat intermediate stage hepatocellular carcinoma (HCC). Postembolisation syndrome (PES) is the most common side effect from TACE and there is still no standard prevention guideline.
AIM
To evaluate the efficacy of single dose intravenous dexamethasone regimen to prevent PES after TACE among patients with HCC.
METHODS
This study enrolled patients with HCC who had eligible indication for TACE without macrovascular invasion/extrahepatic metastasis. Patients were randomly assigned to either an intravenous single dose of dexamethasone 8 mg or placebo one hour before TACE. The primary outcome was a negative result of PES at 48 h after TACE, which was defined as score < 2 of Southwest Oncology Group toxicity coding criteria using fever, nausea, vomiting and pain to calculated. And the secondary end point was duration of admission between two groups.
RESULTS
One hundred patients were randomly assigned 1:1. Under intention-to-treat analysis, 49 patients were randomly assigned to the dexamethasone and 51 to the placebo groups. Both groups were similar for baseline characteristics. The negative PES rate was significantly higher in the dexamethasone group than in the placebo group (63.3% vs 29.4%; P = 0.005). Mean Southwest Oncology Group toxicity coding PES was 2.14 (95%CI: 1.41-2.8) vs 3.71 (95%CI: 2.97-4.45) between the dexamethasone and placebo groups, respectively. Cumulative incidence of fever was significantly lower in dexamethasone group with P < 0.001, pain, nausea and vomiting were also lower in the dexamethasone group compared with the placebo group (P = 0.16, P = 0.11, and P = 0.49). The dexamethasone regimen was generally well tolerated by patients with HCC patients including those with hepatitis B virus infection and well-controlled diabetes mellitus.
CONCLUSION
Single dose dexamethasone was effective at preventing PES among patients with HCC treated with TACE. The study showed no adverse events of special interest related to dexamethasone.
Core Tip: Even in the immuno-oncology era, transcatheter arterial chemoembolisation (TACE) is the most effective way to treat intermediate stage hepatocellular carcinoma. Postembolisation syndrome (PES) is the most common side effect from TACE and there is still no standard prevention guideline. In the present study we report the method to prevent PES, the most common adverse event after TACE in intermediate stage hepatocellular carcinoma patients, by using single dose dexamethasone.
