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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE+EGM | Experimental | Occlude APS with EGM and perform TACE sequentially |
|
| TACE+PVA | Active Comparator | Occlude APS with PVA and perform TACE sequentially |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | Transarterial chemoembolisation (TACE) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall 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. | 3 years |
| APS improvement | Changes of Arterioportal Shunts Treated with PVA or EGM | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 8 weeks, upto 3 years from date of randomization |
| progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibin Shi, MD, PhD. | Contact | 086-025 681 369 18 | shihb@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haibin Shi, MD, PhD. | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| EGM |
| Drug |
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM) |
|
| PVA | Drug | Occlude arterioportal shunts(APS) with PVA |
|
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored. |
| every 8 weeks, upto 3 years from date of randomization |
| Response Rate | Definition of response is based on the mRECIST criteria. | every 8 weeks, upto 3 years from date of randomization |
| Zhong da hospital, Southeast university | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |