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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07490405

Acronym

LSD、TIPS

Enrollment

140

Registered

2026-03-24

Start date

2026-04-01

Completion date

2036-04-01

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis, LSD, TIPS

Brief 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, 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.

Interventions

PROCEDURELSD

laparoscopic splenectomy and azygoportal disconnection

PROCEDURETIPS

Transjugular Intrahepatic Portosystemic Shunt

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
overall survival rate	5-year	overall survival rate

Countries

China

Contacts

CONTACTGuoqing Jiang, MD

jgqing2003@hotmail.com18051060606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026