Table 1 Patient eligibility criteria for INSTIPHE trial
Inclusion criteria | Exclusion criteria |
|---|---|
• Written informed consent | • Imaging confirmed portal vein thrombosis |
• Aged 18–75 years old | • History of overt hepatic encephalopathy |
• Clinically or histologically diagnosed HBV-related cirrhosis by clinical presentations, laboratory tests, images, and liver biopsies) | • History of TIPS or shunt surgery (including splenectomy, surgical disconnection, or shunt) |
• History of GOV bleeding confirmed by endoscopy | • Serial ammonia concentration ≥ 100μmol/L |
• Rebleeding of GOV after receiving non-selective β-blockers (NSBBs) combined with endoscopic therapy | • Severe liver insufficiency (total bilirubin > 51μmol/L) |
• Child-Pugh A or B | • Consolidation of refractory ascites |
• Imaging (CT or MRI) suggests that the left/right first branch portal vein of the intrahepatic portal can construct a shunt | • Malignancy or other serious medical illness that may reduce life expectancy |
• Adequate hematological function: Neutrophils ≥1500/mm3, Platelets ≥50,000/mm3, Prothrombin Time (PT) does not exceed the upper limit of normal control for 3 seconds | • Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or other severe cardiopulmonary diseases |
• Adequate kidney function: Creatinine <150 μmol/L | • Uncontrolled systemic infection or sepsis |