Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and H… (NCT07490405) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism
China140 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Age 18-75 years.
✓. Patient provides written informed consent.
Exclusion criteria
✕. 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).