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NCT Number: NCT07490405

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LSD

Procedure

laparoscopic splenectomy and azygoportal disconnection

TIPS

Procedure

Transjugular Intrahepatic Portosystemic Shunt

Primary outcomes

  1. overall survival rate

    Time frame: 5-year

    overall survival rate

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqing Jiang, MD

CONTACT

[email protected]

18051060606

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study 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

Acronym: LSD、TIPS

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Mar 24, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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