Liver Cirrhosis,Gastroesophageal varices bleeding
Conditions
Interventions
Standard TIPS:In the group, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm H
Underdilated TIPS:In the group, the TIPS stent was underdilated using a 6-mm balloon, and the immediate post-procedure portal pressure gradient (PPG) was measured.
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years; 2.Diagnosis of liver cirrhosis based on clinical and imaging findings according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology); histological confirmation required if diagnosis is inconclusive; 3.High-risk acute variceal bleeding, defined as presence of any of the following: Child-Pugh class C; Child-Pugh class B with active endoscopic evidence of bleeding; early rebleeding within 5 days; or failure of pharmacologic and endoscopic therapy to control bleeding; 4.History of esophagogastric variceal bleeding with documented failure of standard first-line therapy (endoscopic intervention plus nonselective beta-blocker, NSBB); 5.Scheduled to undergo TIPS; 6.Hepatic and renal function meeting all of the following criteria: Child-Pugh score <=13; AST and ALT <5× upper limit of normal (ULN); serum creatinine <1.5× ULN; 7.Ability and willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension; 2.current or prior malignancy, including hepatocellular carcinoma or extrahepatic malignancies; 3.complete thrombosis of the main portal vein; 4.severe psychiatric or neurological disorders (e.g., uncontrolled epilepsy, dementia); 5.history of liver resection or liver transplantation; 6.prior TIPS or surgical portosystemic shunt; 7.pregnancy or lactation; 8.any contraindication to TIPS, including severe right or left ventricular dysfunction, moderate-to-severe pulmonary hypertension despite optimal medical therapy, untreated severe valvular heart disease, or uncontrolled systemic infection; 9.acute variceal hemorrhage with MELD score >=30 and/or arterial lactate >12 mmol/L, or presentation with acute-on-chronic liver failure (ACLF); 10.severe or refractory overt hepatic encephalopathy in the absence of a correctable spontaneous portosystemic shunt; 11.systemic conditions requiring ongoing systemic treatment with glucocorticoids or nonsteroidal anti-inflammatory drugs (NSAIDs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of gastroesophageal variceal rebleeding; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause rebleeding;Stent dysfunction;New or worsening ascites;Incidence of overt hepatic encephalopathy;Liver function;Liver transplantation-free survival; | — |
Countries
China
Contacts
Public ContactTie Jun
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed