A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
NCT ID: NCT07087041
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
735 participants
OBSERVATIONAL
2025-07-15
2028-12-30
Brief Summary
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* 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.
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Detailed Description
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Participants will be grouped based on whether they have had decompensation within the past 12 months. Researchers will regularly collect clinical data, spleen stiffness measurements, and lab tests, to develop and validate a model that predicts recompensation and stable recompensation. The study will also assess the cumulative incidence of clinical events (e.g., further decompensation, hepatocellular carcinoma, liver transplantation, and death) over a two-year follow-up period. Predictive accuracy, model calibration, and discrimination will be evaluated using standard statistical methods, including competing risk models and AUROC analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Recompensation group
≥12 months since the last decompensated event
No interventions assigned to this group
Non-recompensation group
\<12 months since the last decompensated event
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Hong You
Dr
Principal Investigators
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Hong You, Prof.
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Foshan Traditional Chinese Medicine Hospital
Foshan, Guangdong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Panyu Central Hospital
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai
Zhuhai, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Taihe Hospital, Shiyan
Shiyan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Nanjing Second Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Jincheng People's Hospital
Jincheng, Shanxi, China
Jinzhong People's Hospital
Jinzhong, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-P2-244-01
Identifier Type: -
Identifier Source: org_study_id
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