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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNorthern Jiangsu People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • LSD

    Procedure/Surgery

    laparoscopic splenectomy and azygoportal disconnection

  • TIPS

    Procedure/Surgery

    Transjugular Intrahepatic Portosystemic Shunt

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: LSD1 intervention
Group B: TIPS1 intervention

Trial outcomes

Primary outcomes

1

overall survival rate

overall survival rate

Time frame
5-year

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: