Not yet recruitingN/A

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

NCT07490405 · LSD、TIPS · Northern Jiangsu People's Hospital

Closed to entry

Status

Not accepting participants

Not applicable

Phase

140

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

overall survival rate
Measured over 5-year

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years

Ages

All

Sex

Not accepted

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.

Where

1 study site

Facility	City	Region	Country
Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07490405 on ClinicalTrials.gov →

Last updated in the registry 2026-05-18. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Indication

Cirrhosis, Liver3

All 4 trials from Northern Jiangsu People's Hospital →