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Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework for Post-Hepatectomy Liver Failure Prediction

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ClinicalTrials.gov Identifier: NCT06031818
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : February 6, 2024
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Maastricht University

Tracking Information
First Submitted Date September 4, 2023
First Posted Date September 11, 2023
Last Update Posted Date February 6, 2024
Actual Study Start Date December 10, 2023
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2023)
Clinical effectiveness of the explanation framework [ Time Frame: From enrollment to the end of trial at 8 weeks ]
The accuracy, sensitivity and specificity will be compared between the prediction made with and without the explanation of the DL model to determine the clinical effectiveness of the explanation framework.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 6, 2023)
Usability of the explanation framework [ Time Frame: From enrollment to the end of trial at 8 weeks ]
The score of the Likert scale of a designed questionnaire is used to evaluate the usability of the framework. Each item is given a score from 1 to 5. Higher scores mean a better outcome.
Original Secondary Outcome Measures
 (submitted: September 4, 2023)
Usability of the explanation framework [ Time Frame: From enrollment to the end of trial at 8 weeks ]
The score of the Likert scale of a designed questionnaire is used to evaluate the usability of the framework
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework for Post-Hepatectomy Liver Failure Prediction
Official Title Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework (VAE-MILP) Using Counterfactual Explanations and Layerwise Relevance Propagation Framework for Post-Hepatectomy Liver Failure Prediction
Brief Summary

The goal of this in-silico clinical trial is to learn about the usability and clinical effectiveness of an interpretable deep learning framework (VAE-MLP) using counterfactual explanations and layerwise relevance propagation for prediction of post-hepatectomy liver failure (PHLF) in patients with hepatocellular carcinoma (HCC). The main questions it aims to answer are:

  • To investigate the usability of the VAE-MLP framework for explanation of the deep learning model.
  • To investigate the clinical effectiveness of VAE-MLP framework for prediction of post-hepatectomy liver failure in patients with hepatocellular carcinoma.

In the usability trial the clinicians and radiologists will be shown the counterfactual explanations and layerwise relevance propagation (LRP) plots to evaluate the usability of the framework.

In the clinical trial the clinicians and radiologists will make the prediction under two different conditions: with model explanation and without model explanation with a washout period of at least 14 days to evaluate the clinical effectiveness of the explanation framework.

Detailed Description

Post-hepatectomy liver failure (PHLF) is a severe complication after liver resection. It is important to develop an interpretable model for predicting PHLF in order to facilitate effective collaboration with clinicians for decision-making. Two-dimensional shear wave elastography (2D-SWE) is a liver stiffness measurement (LSM) technology that was proven to be useful in liver fibrosis staging. Therefore 2D-SWE shows the potential value for liver function assessment and PHLF prediction. 2D-SWE images display color-coded tissue stiffness map of liver parenchyma, with red representing a solid tissue (higher stiffness) and blue representing a soft tissue (lower stiffness). Routine analysis of 2D-SWE fails to fully utilize all information available in the images and also suffers from inter-observer variance in choosing the optimal quantification region.

Deep learning (DL) has demonstrated state-of-the-art performance on many medical imaging tasks such as classification or segmentation. However, despite significant progress in DL, the clinical translation of DL tools has so far been limited, partially due to a lack of interpretability of models, the so-called "black box" problem. Interpretability of DL systems is important for fostering clinical trust as well as timely correcting any faulty processes in the algorithms.

Here, the investigators present a novel interpretable DL framework (VAE-MLP) which incorporates counterfactual analysis for the explanation of 2D medical images and LRP for the explanation of feature attributions of both medical images and clinical variables.

The goal of this in-silico clinical trial is to learn about the usability and clinical effectiveness of an interpretable deep learning framework (VAE-MLP) using counterfactual explanations and layerwise relevance propagation for prediction of post-hepatectomy liver failure (PHLF) in patients with hepatocellular carcinoma. The main questions it aims to answer are:

  • To investigate the usability of the the interpretable deep learning framework (VAE-MLP) for explanation of the deep learning model.
  • To investigate the clinical effectiveness of the interpretable deep learning framework (VAE-MLP) for prediction of post-hepatectomy liver failure in patients with hepatocellular carcinoma.

In the usability trial the clinicians and radiologists will be shown the counterfactual explanations and layerwise relevance propagation plots of 6 examples. The score of the Likert scale of a designed questionnaire is used to evaluate the usability of the framework.

In the clinical trial the clinicians and radiologists will make the prediction under two different conditions: with model explanation and without model explanation with a washout period of at least 14 days. The accuracy, sensitivity and specificity is used to compare the clinical effectiveness of the explanation framework.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who underwent curative liver resection for HCC.
Condition
  • Post-hepatectomy Liver Failure
  • Hepatocellular Carcinoma
  • Artificial Intelligence
Intervention
  • Other: The explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation
    The radiologist and clinicians will be provided the model prediction results with the explanation of the model and they will fill in a questionnaire to evaluate the usability of the interpretable framework.
  • Other: The model prediction
    The radiologist and clinicians will be provided the model prediction results without the explanation of the model and they will be asked to give their own prediction.
  • Other: The model prediction and the explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation
    The radiologist and clinicians will be provided the model prediction results with the explanation of the model and they will be asked to give their own prediction.
Study Groups/Cohorts Patients with HCC
Patients who underwent curative liver resection for HCC in the First Affiliated Hospital of Sun Yat-Sen University in China.
Interventions:
  • Other: The explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation
  • Other: The model prediction
  • Other: The model prediction and the explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 4, 2023)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 15, 2024
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. patients with treatment-naive and resectable HCC;
  2. performance status Eastern Cooperative Oncology Group (PS) score 0-1.

Exclusion Criteria:

  1. liver resection was not performed;
  2. pathological diagnosis of non-HCC;
  3. failure in liver stiffness measurement defined as the elastography color map was less than 75% filled or interquartile range (IQR)/median > 30%;
  4. immune-active chronic hepatitis indicated by an elevation of alanine aminotransferase (ALT) levels ≥ 2×upper limit of normal (ULN);
  5. obstructive jaundice or dilated intrahepatic bile ducts with a diameter of >3 mm;
  6. hypoalbuminemia, hyperbilirubinemia, or coagulopathy not related to the liver.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Xian Zhong 86-13632460144 x.zhong@maastrichtuniversity.nl
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT06031818
Other Study ID Numbers Interpretable DL
92059201 ( Other Grant/Funding Number: National Natural Science Foundation of China )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Individual participant data (IPD) can be shared if asked
Current Responsible Party Maastricht University
Original Responsible Party Same as current
Current Study Sponsor Maastricht University
Original Study Sponsor Same as current
Collaborators First Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Philippe Lambin Maastricht University
PRS Account Maastricht University
Verification Date February 2024