NCT07490405Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Mar 2031
- Lead sponsor
- Northern Jiangsu People's Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07490405
What you commit to
- Study type: Observational
- Planned participants: 140
- From 1 Jun 2026 to the primary completion date, 1 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.
Other illness
- 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 contrast agent allergy (affecting TIPS procedure).
- Any severe non-hepatic disease with a life expectancy \<1 year.
Other
- Pregnancy or lactation.
- Recent gastric and duodenal ulcers.
- Inability to comply with follow-up or provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.