Evidence map›Paper›PMID 39248039›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2024

Digital quantitation of bridging fibrosis and septa reveals changes in natural history and treatment not seen with conventional histology.

Nikolai V Naoumov, David E Kleiner, Elaine Chng, Dominique Brees, Chandra Saravanan, Yayun Ren, Dean Tai, Arun J Sanyal

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Digital quantitation of bridging fibrosis and septa reveals changes in natural history and treatment not seen with conventional histology.Liver international : official journal of the International Association for the Study of the Liver · 2024
    Trial
  2. Observational
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Nikolai V NaoumovDivision of Medicine, University College London, London, UK.ORCID 0009-0009-3091-4990
David E KleinerLaboratory of Pathology, Post-Mortem Section, National Cancer Institute, Bethesda, Maryland, USA.ORCID 0000-0003-3442-4453
Elaine ChngHistoindex Pte. Ltd., Singapore, Singapore.
Dominique BreesNovartis Pharma AG, Basel, Switzerland.
Chandra SaravananNovartis Institute of Biomedical Research, Cambridge, Massachusetts, USA.ORCID 0000-0003-3214-5696
Yayun RenHistoindex Pte. Ltd., Singapore, Singapore.
Dean TaiHistoindex Pte. Ltd., Singapore, Singapore.
Arun J SanyalStravitz-Sanyal Institute of Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.ORCID 0000-0001-8682-5748

Funding

Postmortem PathologyZ01BC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID E · 2005 to 2008
$913k
HistoIndex Pte. LtdIntramural NIH HHS Z01 BC010685National Institutes of Health, National Cancer InstituteNovartis Pharma AG
6 · The paper itself

Abstract

BACKGROUND AND

aimsMetabolic dysfunction-associated steatohepatitis (MASH) with bridging fibrosis is a critical stage in the evolution of fatty liver disease. Second harmonic generation/two-photon excitation fluorescence (SHG/TPEF) microscopy with artificial intelligence (AI) provides sensitive and reproducible quantitation of liver fibrosis. This methodology was applied to gain an in-depth understanding of intra-stage fibrosis changes and septa analyses in a homogenous, well-characterised group with MASH F3 fibrosis.

methodsPaired liver biopsies (baseline [BL] and end of treatment [EOT]) of 57 patients (placebo, n = 17 and tropifexor n = 40), with F3 fibrosis stage at BL according to the clinical research network (CRN) scoring, were included. Unstained sections were examined using SHG/TPEF microscopy with AI. Changes in liver fibrosis overall and in five areas of liver lobules were quantitatively assessed by qFibrosis. Progressive, regressive septa, and 12 septa parameters were quantitatively analysed.

resultsqFibrosis demonstrated fibrosis progression or regression in 14/17 (82%) patients receiving placebo, while the CRN scoring categorised 11/17 (65%) as 'no change'. Radar maps with qFibrosis readouts visualised quantitative fibrosis dynamics in different areas of liver lobules even in cases categorised as 'No Change'. Measurement of septa parameters objectively differentiated regressive and progressive septa (p < .001). Quantitative changes in individual septa parameters (BL to EOT) were observed both in the 'no change' and the 'regression' subgroups, as defined by the CRN scoring.

conclusionSHG/TPEF microscopy with AI provides greater granularity and precision in assessing fibrosis dynamics in patients with bridging fibrosis, thus advancing knowledge development of fibrosis evolution in natural history and in clinical trials.

Indexed as

LiverLiver CirrhosisAdultArtificial IntelligenceBiopsyDisease ProgressionFatty LiverFemaleHumansMaleMicroscopy, Fluorescence, MultiphotonMiddle Ageddigital pathology with artificial intelligenceliver fibrosismetabolic dysfunction‐associated steatohepatitisquantitative assessment fibrosis regressionsecond harmonic generation microscopy

Identifiers

PMID39248039
PMCPMC11586893

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.