Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LSD, TIPS.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-term Efficacy and Safety of Laparoscopic Splenectomy and Azygoportal Disconnection Versus Transjugular Intrahepatic Portosystemic Shunt for Cirrhotic Portal Hypertension With Acute Esophagogastric Variceal Bleeding and Hypersplenism
Overview
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.
Interventions
- Procedure LSD
laparoscopic splenectomy and azygoportal disconnection - Procedure TIPS
Transjugular Intrahepatic Portosystemic Shunt
Primary outcome measures
- overall survival rate [Time frame: 5-year]
Eligibility criteria
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).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Northern Jiangsu People's Hospital — Yangzhou
Identifiers
NCT: NCT07490405 · YZUC-018