Decompensated CirrhosisD-TECTNCT07880678
Risk Stratification for Adverse Events in End-Stage Liver Disease
An observational study of Decompensated Cirrhosis, run by The Second Affiliated Hospital of Chongqing Medical University.
Trial summary
Study Goal The goal of this multicenter, prospective observational cohort study is to develop and validate a multimodal predictive model that integrates portal hypertension, inflammation, and liver function indicators to predict the risk of adverse clinical outcomes (e.g., further decompensation, mortality… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Routine Clinical Care with Biospecimen Collection and Free MRE Testing
- How many people
- 2,235 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2031
- Phase
- Observational
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18-80 years) with decompensated cirrhosis of any etiology, having at least one prior decompensation event (ascites, variceal bleeding, encephalopathy, jaundice >3 mg/dL, or infection). Excludes active malignancy (except curable skin/thyroid), prior transplant, critical illness (survival <72h), and pregnancy.
Who may be able to join
- Age ≥18 years and ≤80 years at the time of signing informed consent, regardless of sex.
- Diagnosis of chronic liver disease of any etiology (including but not limited to viral hepatitis, alcoholic liver disease, fatty liver disease, etc.).
- Have experienced at least one decompensating event prior to or at enrollment, defined as any of the following:
- ① Gastroesophageal variceal bleeding confirmed by endoscopy;
- ② Overt hepatic encephalopathy;
- ③ Moderate to large ascites confirmed by imaging, or requiring paracentesis for therapeutic drainage;
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- ④ Jaundice (serum total bilirubin >3 mg/dL);
- ⑤ Infection requiring treatment.
- Voluntarily sign a written informed consent form.
Who cannot join
- Diagnosis of malignant tumor (including solid tumors and hematological malignancies) at enrollment, except for curable thyroid cancer and basal cell carcinoma of the skin.
- History of liver transplantation.
- Hemodynamically unstable with an expected survival of less than 72 hours.
- Pregnant or lactating women.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation (e.g., inability to comply with follow-up, severe psychiatric disorders, etc.).
About this study
Official title: Establishment and Validation of a Risk Stratification System for Adverse Events in End-Stage Liver Disease
Study Goal The goal of this multicenter, prospective observational cohort study is to develop and validate a multimodal predictive model that integrates portal hypertension, inflammation, and liver function indicators to predict the risk of adverse clinical outcomes (e.g., further decompensation, mortality, recompensation, and liver failure) in patients with decompensated cirrhosis.
Target Population The study will enroll adults aged 18-80 years with chronic liver disease of any etiology who have experienced at least one decompensating event (e.g., ascites, variceal bleeding, overt hepatic encephalopathy, jaundice, or infection requiring treatment) at or prior to enrollment.
Read more
Main Questions It Aims to Answer
- How accurately can the multimodal model predict the risk of further decompensation (e.g., recurrent ascites, rebleeding, spontaneous bacterial peritonitis, or hepatorenal syndrome-AKI) within 1 year of enrollment?
- Can the model reliably predict 6-week, 1-year, and 2-year liver-related mortality, as well as the incidence of liver failure and the probability of recompensation (per Baveno VII criteria), and does it outperform traditional scoring systems?
Comparison Group Researchers will compare the performance of the newly developed multimodal model against established traditional prognostic tools, including the MELD, MELD-Na, and Child-Pugh scores, to assess whether the new model provides superior predictive accuracy, better risk reclassification, and greater clinical net benefit.
Participants Will
- Provide written informed consent before any study-related data collection.
- Undergo baseline and routine 3-month follow-up assessments (aligned with their standard clinical care) over a total of 3 years, during which clinical data, laboratory tests, and imaging results will be recorded.
- Voluntarily provide additional biospecimens (peripheral blood 10 mL, 3 stool tubes, and 10 mL urine) at baseline and during return visits for exploratory biomarker and multi-omics analysis (participants who provide samples receive a ¥200 nutritional subsidy; those undergoing clinically indicated MRI also receive free MRE testing).
- Conditions
- Decompensated Cirrhosis
- Being tested
- Routine Clinical Care with Biospecimen Collection and Free MRE Testing
- Keywords
- decompensation, recompensation, algorithm, portal hypertension, imflamation
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical Care with Biospecimen Collection and Free MRE TestingDiagnostic test
Participants receive standard-of-care medical management for decompensated cirrhosis, including regular 3-month follow-up visits, laboratory tests, and imaging examinations, as determined by their treating physicians per clinical practice guidelines. No study-specific therapeutic interventions, randomization, or treatment allocation are applied.
In addition, participants who provide voluntary informed consent will undergo the following study-related procedures:
Free magnetic resonance elastography (MRE) examination, offered to participants who are clinically scheduled for a routine abdominal MRI, to assess liver stiffness and fibrosis non-invasively at no cost.
All data collected (demographics, clinical history, laboratory results, imaging findings, and patient-reported outcome scales) are derived from routine clinical care and are used solely for prognostic model development and validation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Further Decompensation at 1 Year
Further decompensation is defined per Baveno VII criteria as any of the following: (1) occurrence of a second portal hypertension-related decompensating event (ascites, variceal bleeding, or hepatic encephalopathy); (2) recurrent variceal bleeding, recurrent ascites requiring ≥3 large-volume paracenteses within 1 year, recurrent hepatic encephalopathy, spontaneous bacterial peritonitis, and/or hepatorenal syndrome-acute kidney injury; or (3) development of ascites or hepatic encephalopathy after surgery in patients with variceal bleeding as the sole prior event.
Measured: Within 12 months after enrollment
Secondary outcomes (5)
6-Week Liver-Related Mortality Rate
Death directly attributed to liver disease or its immediate complications (e.g., liver failure, variceal rebleeding, infections).
Measured: Within 6 weeks after enrollment
1-Year Liver-Related Mortality Rate
Death directly attributed to liver disease or its immediate complications (e.g., liver failure, variceal rebleeding, infections).
Measured: Within 12 months after enrollment
Incidence of Liver Failure at 1 Year
Defined per 2023 EASL ACLF criteria: total bilirubin ≥12 mg/dL plus any of: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for RRT; (3) hepatic encephalopathy ≥ grade 3 (West Haven); (4) need for vasopressors; or (5) PaO₂/FiO₂ ≤200 or SpO₂/FiO₂ ≤214.
Measured: Within 12 months after enrollment
Recompensation Rate at 2 Years
Per Baveno VII consensus: sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding with stable improvement in liver function for ≥12 months after etiological treatment.
Measured: Within 24 months after enrollment
Recompensation Rate at 3 Years
Per Baveno VII consensus: sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding with stable improvement in liver function for ≥12 months after etiological treatment.
Measured: Within 36 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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
- 2,235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JinjunChen, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880678
- Sponsor's protocol ID
- 2026-IIT-SL-217
- Acronym
- D-TECT
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No