About this trial
This study aims to compare two treatments for cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism: laparoscopic splenectomy and azygoportal disconnection (LSD) and transjugular intrahepatic portosystemic shunt (TIPS). It is a single-center, prospective trial. The primary outcome is the incidence of post-procedure hepatic encephalopathy. Secondary outcomes include changes in hepatic venous pressure gradient, portal and hepatic artery hemodynamics, liver function, renal function, complete blood count, immune function, hepatic reserve capacity, serological markers of liver fibrosis, re-bleeding rate, hepatocellular carcinoma incidence, recompensation incidence, overall survival, and bleeding-free survival. The study will provide high-level evidence for optimal treatment selection in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of cirrhotic portal hypertension.
Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment..
Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia.
Liver function Child-Pugh class A or B (score 7-9).
Disqualifiers
Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score >18.
Severe right heart failure or pulmonary hypertension.
Uncontrolled systemic infection or sepsis.
Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation).
Trial population
Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism
Trial design
Cohort
Prospective
Treatments tested in this trial
LSD
Procedure/Surgerylaparoscopic splenectomy and azygoportal disconnection
TIPS
Procedure/SurgeryTransjugular Intrahepatic Portosystemic Shunt
Treatment groups
Trial outcomes
Primary outcomes
overall survival rate
overall survival rate
Sponsors and contacts
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