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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
TIPS was performed within 72 hours after the endoscopic hemostasis.
Chinese PLA General hospital
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General hospital
Beijing, Beijing Municipality, China
RECRUITINGRates of technical success
Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.
Time frame: 3 months
Rates of gastrointestinal hemorrhage
Patients occur gastrointestinal hemorrhage within 6 months after TIPS.
Time frame: 6 months
Progression-Free-Survival (PFS)
Progression was defined as progressive disease by independent radiologic review.
Time frame: 12 months
Overall survival (OS)
OS is the length of time from the date of inclusion until death from any cause.
Time frame: 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.
Time frame: 12 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03.
Time frame: 12 months
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