A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
LEAD-2
Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study
1 other identifier
observational
735
1 country
28
Brief Summary
The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are:
- Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse?
- What are the features of people who recover after decompensation? Participants will:
- Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence)
- Be followed over time to check if they remain stable or have more liver problems
- Have non-invasive tests done, including spleen stiffness measurement and blood tests Researchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Typical duration for all trials
28 active sites
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
July 4, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
July 25, 2025
July 1, 2025
3.3 years
July 4, 2025
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation
The primary outcome of this study is the accuracy of a non-invasive prediction model based on spleen stiffness and routine laboratory markers in identifying recompensation and stable recompensation in individuals with decompensated cirrhosis.
2 years
Secondary Outcomes (8)
Discrimination, calibration, and stability of the prediction model
2 years
Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation
2 years
Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation
2 years
Predictive accuracy of platelets in identifying recompensation and stable recompensation
2 years
Cumulative incidence of recompensation by etiology
2 years
- +3 more secondary outcomes
Study Arms (2)
Recompensation group
≥12 months since the last decompensated event
Non-recompensation group
\<12 months since the last decompensated event
Eligibility Criteria
Adults aged 18 to 75 years with decompensated cirrhosis who are receiving and maintaining effective treatment for the underlying cause of liver disease. The first decompensation event must be clinically significant ascites and/or variceal bleeding. Participants must have either experienced their first decompensation within the past 12 months or remained free from new decompensation events during the past 12 months.
You may qualify if:
- Male or female, aged 18 to 75 years (inclusive)
- Clinically diagnosed decompensated cirrhosis
- First decompensated event occurred within 12 months of screening, or no decompensated events in the past 12 months despite a history of decompensation
- Received effective etiological treatment per guidelines:
- For HBV: Sustained antiviral suppression
- For alcohol-related liver disease: Sustained abstinence for ≥2 months
- For MAFLD-related cirrhosis: Improved liver function after lifestyle/ metabolic intervention
You may not qualify if:
- Missing data on first decompensated event
- Prior orthotopic liver transplantation or TIPS
- Prior splenectomy, splenic embolization, or other shunt surgery
- History or current diagnosis of hepatocellular carcinoma
- Acute variceal bleeding within the last 4 weeks or unstable condition
- Uncontrolled moderate-to-severe ascites
- Cholestatic cirrhosis; untreated chronic liver diseases; non-cirrhotic portal hypertension; vascular liver diseases (e.g., Budd-Chiari syndrome)
- Acute or chronic portal vein thrombosis
- Severe comorbidities of heart, lung, kidney, brain, hematologic, or psychiatric systems
- Other systemic malignancies (except cured cases)
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Foshan Traditional Chinese Medicine Hospital
Foshan, Guangdong, 528000, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Panyu Central Hospital
Guangzhou, Guangdong, 511400, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai
Zhuhai, Guangdong, 519000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Taihe Hospital, Shiyan
Shiyan, Hubei, 442000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
Nanjing Second Hospital
Nanjing, Jiangsu, 210003, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266071, China
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
Changzhi People's Hospital
Changzhi, Shanxi, 046000, China
Jincheng People's Hospital
Jincheng, Shanxi, 048000, China
Jinzhong People's Hospital
Jinzhong, Shanxi, 030600, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong You, Prof.
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 4, 2025
First Posted
July 25, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary study results.
- Access Criteria
- Qualified researchers affiliated with academic or medical institutions will be able to request access to the de-identified individual participant data (IPD) and supporting documents (such as study protocol and statistical analysis plan). All requests will be reviewed and approved by the study steering committee.
The individual participant data to be shared include de-identified demographic information, clinical characteristics, laboratory test results (including spleen stiffness, liver stiffness, platelet counts, and other routine blood tests), treatment details, and clinical outcomes related to recompensation and stable recompensation.