Liver CirrhosisLSD、TIPSNCT07490405
Long-term Efficacy and Safety of LSD Versus TIPS for Cirrhotic Portal Hypertension Bleeding and Hypersplenism
An observational study of Liver Cirrhosis, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- LSD and TIPS
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Apr 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Guoqing Jiang, MD, 18051060606, jgqing2003@hotmail.com
About this study
Official 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
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.
- Conditions
- Liver Cirrhosis
- Being tested
- LSD, TIPS
- Keywords
- Liver Cirrhosis, LSD, TIPS
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSDProcedure or surgery
laparoscopic splenectomy and azygoportal disconnection
TIPSProcedure or surgery
Transjugular Intrahepatic Portosystemic Shunt
| Study group | Role | What they receive |
|---|---|---|
| LSD | Not described Receives: Procedure: LSD | |
| TIPS | Not described Receives: Procedure: TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
overall survival rate
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490405
- Sponsor's protocol ID
- YZUC-018
- Acronym
- LSD、TIPS
- Status last verified
- May 2026
- First submitted
- 18 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07490405
- Acronym / sponsor ID
- LSD、TIPS / YZUC-018
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, LSD, TIPS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Apr 2036 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSD | – | Procedure: LSD |
| TIPS | – | Procedure: TIPS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSDlaparoscopic splenectomy and azygoportal disconnection | Procedure or surgery | LSD |
| TIPSTransjugular Intrahepatic Portosystemic Shunt | Procedure or surgery | TIPS |
Primary outcome
overall survival rate
Time frame: 5-year
overall survival rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqing Jiang, MD (18051060606, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: 5-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.