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

N/ANot Yet RecruitingNCT07490405

Northern Jiangsu People's Hospital140 enrolled

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, 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Liver Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts