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

Northern Jiangsu People's Hospital

Status: Not yet enrolling

Conditions: Liver Cirrhosis

Treatments: Procedure: LSD; Procedure: TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT07490405

YZUC-018

Details and patient eligibility

About

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, randomized controlled, superiority 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, overall survival, and bleeding-free survival. The study will provide high-level evidence for optimal treatment selection in this patient population.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

LSD

Experimental group

Treatment:

Procedure: LSD

TIPS

Active Comparator group

Treatment:

Procedure: TIPS