Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia. Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC). The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Transarterial chemoembolisation (TACE)
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
Occlude arterioportal shunts(APS) with PVA
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGZhong da hospital, Southeast university
Nanjing, Jiangsu, China
RECRUITINGoverall survival
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
Time frame: 3 years
APS improvement
Changes of Arterioportal Shunts Treated with PVA or EGM
Time frame: 2 month
Time To Progression
Time from randomization to radiological progression. Definition of progression is based on the mRECIST criteria. Deaths during follow-up without evidence of radiological progression are censored.
Time frame: every 8 weeks, upto 3 years from date of randomization
progression free survival
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
Time frame: every 8 weeks, upto 3 years from date of randomization
Response Rate
Definition of response is based on the mRECIST criteria.
Time frame: every 8 weeks, upto 3 years from date of randomization
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