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Clinical Trials in China / NCT07490405
Starting soon Observational

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

NCT07490405 · tracked via the Priya Life Science China tracker
Sponsor
Northern Jiangsu People's Hospital
Phase
Observational
Started
2026-06-01
Last updated
2026-05-18

Condition(s) studied

Liver Cirrhosis

Investigational drug(s) / intervention(s)

LSDTIPS

LSD: laparoscopic splenectomy and azygoportal disconnection

TIPS: Transjugular Intrahepatic Portosystemic Shunt

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Confirmed diagnosis of cirrhotic portal hypertension. 2. Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment.. 3. Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia. 4. Liver function Child-Pugh class A or B (score 7-9). 5. Age 18-75 years. 6. Patient provides written informed consent. Exclusion Criteria: 1. Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score \>18. 2. Severe right heart failure or pulmonary hypertension. 3. Uncontrolled systemic infection or sepsis. 4. Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation). 5. Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies. 6. Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication. 7. Severe contrast agent allergy (affecting TIPS procedure). 8. Pregnancy or lactation. 9. Any severe non-hepatic disease with a life expectancy \<1 year. 10. Recent gastric and duodenal ulcers. 11. Inability to comply with follow-up or provide informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Northern Jiangsu People's Hospital Yangzhou Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07490405 on ClinicalTrials.gov ↗ ← All trials in China