Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD (MAFLD)
17 sierpnia 2026 zaktualizowane przez: Hong You, Beijing Friendship Hospital
Exploring the Risk Prediction of Liver-Related Events in Metabolic-Associated Fatty Liver Disease Based on Changes in Liver Stiffness Values Measured by iLivTouch
This is an observational study (multicenter retrospective real-world cohort study).
The purpose of this study is to assess the predictive performance of liver stiffness measurement (LSM, including baseline LSM1, current LSMC and their dynamic changes) acquired by domestic iLivTouch device for liver-related events (LREs) and all-cause mortality among MAFLD patients with compensated advanced chronic liver disease (cACLD), and to explore the prognostic value of dynamic LSM changes.
The study population consists of adult patients aged ≥18 years of either sex, clinically diagnosed with MAFLD-related cACLD (defined as baseline LSM1 ≥10 kPa per Baveno-VII consensus), with at least two LSM measurements separated by ≥12-month follow-up interval, and without other confounding chronic liver diseases, excessive alcohol intake or predefined exclusion comorbidities.
This study aims to answer several major questions: whether dynamic LSM parameters measured by iLivTouch can predict LREs and all-cause mortality in MAFLD-cACLD patients; whether risk of LREs differs between patients with significant LSMC decline and those without such decline in the resolved cACLD subgroup; whether liver-related mortality differs between resolved and persistent cACLD patients; and whether pharmacological interventions influence LRE risk and cACLD resolution.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
2303
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Multicenter retrospective real-world cohort of adult patients (≥18 years) with MAFLD-related compensated advanced chronic liver disease (cACLD, LSM1 ≥10 kPa per Baveno-VII consensus).
Participants must have at least two LSM measurements ≥12 months apart.
Patients with competing chronic liver diseases, excessive alcohol consumption, malignancies, TIPS history, acute liver injury and other predefined conditions are excluded from this study.
Opis
Inclusion Criteria:
- Aged ≥18 years, both male and female.
- Clinically diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and progressed to compensated advanced chronic liver disease (cACLD) according to the 2024 Chinese Guidelines for the Management of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease. cACLD is defined as baseline liver stiffness measurement (LSM1) ≥10 kPa based on the Baveno-VII consensus.
- At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements.
Exclusion Criteria:
- Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc.
- Weekly alcohol intake ≥210 g for men or ≥140 g for women.
- Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value.
- Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value.
- Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value.
- Presence of vascular liver disease, cystic fibrosis-related liver disease, sarcoidosis, polycystic liver disease, congenital or rare inherited liver disease, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure complicated by hepatic venous congestion.
- History of transjugular intrahepatic portosystemic shunt (TIPS).
- Acute hepatitis (alanine aminotransferase >5-fold upper limit of normal) or acute-on-chronic liver failure (ACLF) occurring at the time of LSM1 or LSMC measurement.
- Missing value of either LSM1 or LSMC.
- Any other conditions judged by investigators to be inappropriate for study participation.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality
Ramy czasowe: From the time of baseline LSM1 measurement until occurrence of LREs, death, loss to follow-up, or end-of-study cutoff, assessed up to 10 years
|
Area under the receiver operating characteristic curve (AUC) will be used to evaluate the predictive performance of baseline liver stiffness (LSM1), current liver stiffness (LSMC), and their dynamic changes for liver-related events (LREs) and all-cause mortality in patients with MAFLD-related cACLD.
|
From the time of baseline LSM1 measurement until occurrence of LREs, death, loss to follow-up, or end-of-study cutoff, assessed up to 10 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Difference in risk of LREs between patients with significant LSMC decline versus non-significant LSMC decline within resolved cACLD subgroup
Ramy czasowe: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
|
Cox proportional-hazards model will be applied to compare the risk of liver-related events (LREs) between resolved cACLD patients with significant LSMC decline (≥20 % LSM reduction or LSMC < 10 kPa) and those without significant LSMC decline.
|
From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
|
|
Difference in liver-related mortality risk between resolved cACLD patients and persistent cACLD patients
Ramy czasowe: From baseline LSM1 until liver-related death, death from other causes, loss to follow-up, or study end, up to 10 years
|
Competing-risk regression model will be used to compare liver-related mortality risk between patients with resolved cACLD and patients with persistent cACLD.
|
From baseline LSM1 until liver-related death, death from other causes, loss to follow-up, or study end, up to 10 years
|
|
Association between pharmacological interventions and risk of LREs among cACLD patients
Ramy czasowe: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
|
Cox proportional-hazards model will be used to explore whether different pharmacological interventions are associated with significant differences in the risk of liver-related events (LREs) in cACLD patients.
|
From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years
|
|
Association between pharmacological interventions and cACLD resolution
Ramy czasowe: From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years
|
Logistic regression model will be used to explore whether different pharmacological interventions are associated with significant differences in the probability of cACLD resolution.
|
From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
17 września 2026
Zakończenie podstawowe (Szacowany)
16 października 2027
Ukończenie studiów (Szacowany)
30 października 2027
Daty rejestracji na studia
Pierwszy przesłany
17 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
20 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026-P2-406-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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