How to prophylactically alleviate postembolization syndrome following transarterial chemoembolization?: Protocol of a double blinded, randomized, placebo-controlled trial.

Abstract

INTRODUCTION:

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, and most patients in China are diagnosed at the intermediate or later stages, which is not suitable for the first line therapies. Transarterial chemoembolization (TACE) is a commonly selected therapeutic option for intermediate and later stage HCC in China, but patients often suffer from postembolization syndrome (PES), manifesting as fever, liver area pain, nausea, vomiting, paralyzed intestinal obstruction, and abdominal pain after TACE. We try to conduct a double blinded, randomized, placebo-controlled clinical trial to observe whether Chaihu Guizhi decoction (CGD), a classic traditional Chinese formula, could prophylactically alleviate the incidence of PES in HCC patients after TACE.

METHODS:

Patients will be randomly assigned sequentially in a 1:1 ratio by using preformed randomization envelopes. After TACE procedures, patients in the treatment group will be administrated with Chinese herbal formula CGD, and patients in the control group with CGD simulations, twice a day, continuously for 7 days. The outcomes are the incidence of PES hospitalization and, complications. SPSS version 22 (IBM, Chicago, IL) will be used for the data, and a P < .05 will be considered statistically significant.

CONCLUSIONS:

The findings will explore the prophylactic effect of CGD in alleviating the incidence of PES following TACE in HCC patients.

TRIAL REGISTRATION:

OSF Registration number: DOI 10.17605/OSF.IO/FKRSN.

• Authors: Yi Pan, Rui Chang, Zhonglin He, Ming Hong
• Journal: Medicine (Medicine (Baltimore)) Vol. 100 Issue 14 Pg. e25360 (Apr 09 2021) ISSN: 1536-5964 [Electronic] United States
• PMID: 33832116 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Drugs, Chinese Herbal
• guizhi decoction

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Chemoembolization, Therapeutic (adverse effects, methods)
• Double-Blind Method
• Drugs, Chinese Herbal (administration & dosage, adverse effects)
• Female
• Fever (etiology, prevention & control)
• Humans
• Liver Neoplasms (therapy)
• Male
• Middle Aged
• Nausea (etiology, prevention & control)
• Research Design
• Syndrome
• Vomiting (etiology, prevention & control)
• Young Adult
• Randomized Controlled Trials as Topic