NCT07490405

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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
120mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2036

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

4.8 years

First QC Date

March 18, 2026

Last Update Submit

May 14, 2026

Conditions

Liver Cirrhosis

Keywords

Liver CirrhosisLSDTIPS

Outcome Measures

Primary Outcomes (1)

  • overall survival rate

    overall survival rate

    5-year

Study Arms (2)

LSD

Procedure: LSD

TIPS

Procedure: TIPS

Interventions

LSDPROCEDURE

laparoscopic splenectomy and azygoportal disconnection

LSD
TIPSPROCEDURE

Transjugular Intrahepatic Portosystemic Shunt

TIPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Lysergic Acid DiethylamidePortasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lysergic AcidErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPortasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Central Study Contacts

Guoqing Jiang, MD

CONTACT

18051060606jgqing2003@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

April 1, 2036

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations

CN(1)