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CompletedNCT07675525NIMIT-AIUpdated Jun 30, 2026

Deep Learning for Liver Fibrosis Triage in MASLD Using Longitudinal Electronic Health Records

An observational study in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), sponsored by Siriraj Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Siriraj Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,351
Ages
18 Years and older
Sex
All
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Study summary

This study looks at a new computer program called NIMIT-AI (Neural Inference for Metabolic-liver Integrated Trajectories, Artificial Intelligence) that helps doctors find liver scarring early in patients with fatty liver disease.

Fatty liver disease, also called metabolic dysfunction-associated steatotic liver disease (MASLD), is a common condition where fat builds up in the liver. Over time, this can cause scarring (fibrosis). Finding scarring early helps doctors treat it before it gets worse.

Right now, doctors use a blood test score called FIB-4 to check for scarring. But this score misses many patients and cannot be calculated when blood test results are incomplete.

NIMIT-AI works differently. It reads a patient's blood test results over multiple visits, not just one visit, to spot patterns that suggest liver scarring. It was tested on 969 patients seen at Siriraj Hospital in Bangkok, Thailand between 2018 and 2022.

In testing, NIMIT-AI found liver scarring more accurately than FIB-4. It also worked even when some blood test results were missing, which happens often in real clinics.

This study did not ask patients to do anything extra. It used health records that were already collected as part of regular care.

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Conditions studied

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

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Keywords

  • MASLD
  • Liver Fibrosis
  • Deep Learning
  • Gated Recurrent Unit
  • Non-invasive Triage
  • Longitudinal EHR
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In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 1,351 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adults with confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) receiving outpatient hepatology care at Siriraj Hospital, a 2,500-bed tertiary academic medical centre in Bangkok, Thailand. The population reflects a high metabolic comorbidity burden typical of urban Thai patients, with elevated rates of type 2 diabetes, obesity, and cardiometabolic multimorbidity.

Inclusion criteria

  • Age ≥18 years at index visit
  • Confirmed MASLD diagnosis per Delphi consensus criteria
  • At least one outpatient visit with concurrent laboratory data and FibroScan liver stiffness measurement within observation window (2018-2022)
  • Receiving care at Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University

Exclusion criteria

Exclusion Criteria:

  • Alternative chronic liver disease aetiology (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, haemochromatosis)
  • Chronic viral hepatitis (hepatitis B or C surface antigen positivity)
  • Prior liver transplantation
  • Active extrahepatic malignancy at baseline
  • Insufficient longitudinal data for outcome ascertainment
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,351 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary longitudinal cohort (≥2 visits)

    Diagnostic Test: Longitudinal electronic health record analysis

  • Singleton sensitivity analysis cohort (1 visit)

    Diagnostic Test: Longitudinal electronic health record analysis

Interventions

  • Diagnostic testLongitudinal electronic health record analysis

    NIMIT-AI, a gated recurrent unit deep learning model, analyzed serial outpatient laboratory results from electronic health records collected over a 5-year observation window (2018-2022) at Siriraj Hospital. The model processed up to 10 sequential visits per patient using 18 clinical features including liver enzymes, metabolic markers, comorbidity flags, and medication exposures to predict liver fibrosis stage without requiring elastography.

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What researchers measure

Primary outcomes

  1. Area under the receiver operating characteristic curve (AUROC) for significant fibrosis (F≥2) identification

    Time frame: Assessed at end of observation period (December 2022)

Secondary outcomes

  1. Sensitivity-constrained positive predictive value (PPV) for significant fibrosis (F≥2) at optimised classification threshold

    Time frame: Assessed at end of observation period (December 2022)

  2. Diagnostic performance for compensated advanced chronic liver disease (F3-F4 cACLD) reported as one-vs-rest AUROC

    Time frame: Assessed at end of observation period (December 2022)

  3. Net reclassification improvement (NRI) of NIMIT-AI versus FIB-4 at guideline-recommended threshold (1.30)

    Time frame: Assessed at end of observation period (December 2022)

  4. Integrated discrimination improvement (IDI) of NIMIT-AI versus FIB-4

    Time frame: Assessed at end of observation period (December 2022)

  5. Attention weight distribution across visit positions for temporal interpretability of NIMIT-AI predictions

    Time frame: Assessed at end of observation period (December 2022)

  6. SHAP (SHapley Additive exPlanations) feature importance values for global model interpretability across fibrosis classes

    Time frame: Assessed at end of observation period (December 2022)

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Study locations

1 site
  • Faculty of Medicine Siriraj Hospital
    Bangkok Noi, Bangkok 10700, Thailand
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07675525
Lead sponsor
Siriraj Hospital
Responsible party
Tawesak Tanwandee (Professor, Siriraj Hospital) — Principal investigator
First posted
Jun 30, 2026
Start date
Jan 1, 2018
Primary completion
Dec 31, 2022
Completion
Jun 16, 2024
Last update
Jun 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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