Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism

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Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT07490405

Run by

Northern Jiangsu People's Hospital

People needed

140

Starts

2026-06-01

Expected to finish

2036-04-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies.
• Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.
• Severe contrast agent allergy (affecting TIPS procedure).
• Pregnancy or lactation.
• Any severe non-hepatic disease with a life expectancy <1 year.
• Recent gastric and duodenal ulcers.
• Inability to comply with follow-up or provide informed consent.

Where it is running

• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China

Full record on ClinicalTrials.gov

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