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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.
Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early transjugular intrahepatic portosystemic shunt (TIPS) | Experimental | TIPS was performed within 72 hours after the endoscopic hemostasis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early TIPS | Procedure | TIPS was performed within 72 hours after the endoscopic hemostasis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of technical success | Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of gastrointestinal hemorrhage | Patients occur gastrointestinal hemorrhage within 6 months after TIPS. | 6 months |
| Progression-Free-Survival (PFS) | Progression was defined as progressive disease by independent radiologic review. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfang Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Feng Duan, MD | Contact | 86 13910984586 | duanfeng@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Duan, MD | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.
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TIPS was performed within 72 hours after variceal bleeding.
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| 12 months |
| Overall survival (OS) | OS is the length of time from the date of inclusion until death from any cause. | 12 months |
| Objective response rate (ORR) | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response. | 12 months |
| Adverse events | Safety will be evaluated according to the NCI CTCAE Version 4.03. | 12 months |
| Chinese PLA General hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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