In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices
Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt
Department of Gastroenterology and Hepatology
Shanghai, Shanghai Municipality, China
RECRUITING24-week re-bleeding
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Time frame: 24 weeks
8-week re-bleeding
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
Time frame: 8 weeks
8-week mortality
death
Time frame: 8 weeks
8-week adverse events
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Time frame: 8 weeks
24-week mortality
death
Time frame: 24 weeks
24-week adverse events
Other complications of portal hypertension such as the progression of ascites, liver failure, etc.
Time frame: 24 weeks
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