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Spleen InjuryNCT05643612

Deep Learning Algorithm for Traumatic Splenic Injury Detection and Sequential Localization

An observational study of Spleen Injury and Machine Learning, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spleen laceration is a lethal abdominal trauma and usually be diagnosed by medical images such as computed tomography. Deep learning had been proved its usage in detect abnormalities in medical images. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spleen Injury, Machine Learning
What is being tested?
Deep learning algorithm
How many people
600 participants
Where
1 siteTaiwan
Study dates
1 Feb 2022to 1 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: We enrolled images of the patients who underwent abdominal computed tomography in emergency department for trauma and acute abdominal survey from Jul 2008 to Dec 2017. Then we selected 300 images with splenic injury and 300 images without.

Who may be able to join

  • patients who underwent abdominal computed tomography in emergency department for trauma and acute abdominal survey from Jul 2008 to Dec 2017.

Who cannot join

  • poor quality images
  • no contrast series of computed tomography images.
  • images from other hospitals without proper evaluation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung memorial hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: The Three-dimensional Weakly Supervised Deep Learning Algorithm for Traumatic Splenic Injury Detection and Sequential Localization

Spleen laceration is a lethal abdominal trauma and usually be diagnosed by medical images such as computed tomography. Deep learning had been proved its usage in detect abnormalities in medical images.

In this trial, we used de-identified registry databank to develop a novel deep-learning based algorithm to detect the spleen trauma and to identify the injury locations.

Read the detailed description

Background

Splenic injury is the most common solid visceral injury in blunt abdominal trauma, and high-resolution abdominal computed tomography (CT) can adequately detect the injury. However, these lethal injuries sometime have been overlooked in current practice. Deep learning algorithms have proven their capabilities in detecting abnormal findings in medical images. The aim of this study is to develop a three-dimensional, unsupervised deep learning algorithm for detecting splenic injury on abdominal CT using a sequential localization and classification approach.

Material and Methods

We retrospectively collected data from patients who underwent contrast-enhanced abdominal CT in the emergency department of Chang Gung Memorial Hospital, Linko, due to trauma and acute abdomen from Jul 2008 to Dec 2017. All patients were registered in the trauma and acute abdomen registries. Demographic information, including age, sex, disease diagnosis, trauma mechanism, Injury Severity Score, New Injury Severity Score , Abbreviated Injury Scale, and spleen injury grade, was collected. Scans showing splenic injury were identified as positive, and the remaining scans were defined as negative controls. We identified 300 venous phase scans with splenic injury and randomly selected 300 additional venous phase scans from the negative controls. CT scans with abdominal trauma injuries other than splenic injury were not excluded to reduce the selection bias. All data were split by age, sex, the presence of splenic injury, and injury severity score using stratified sampling into the developmental dataset and the test set at a ratio of 8:2. One-eighth of the developmental dataset was further reserved as the validation set during model construction.

Image preprocessing and labeling

The CT scan images were acquired in the original Digital Imaging and Communications in Medicine (DICOM) format. The images were then converted to the Neuroimaging Informatics Technology Initiative format, producing 3D voxel-based images. Our algorithm was then developed based on the venous axial slices, the most common imaging direction in abdominal trauma surveys. During the training process, image augmentation by translation, rotation, scaling, and elastic distortions was applied to increase model generalizability.

A trauma surgeon with 10 years of experience confirmed all the positive and negative scans. In all scans, the spleen with its surrounding background was covered with a manually drawn 3D bounding box.

Spleen localization

The localization model was designed based on 3D Faster RCNN with Resnet-101as the backbone structure and trained on the development dataset. We used cross-entropy, focal loss as the class loss, and L1 loss, distance intersection over union (DIOU) as box regression loss, and adopted intersection over union (IOU) and DIOU in non-maximum suppression (NMS) for training of the object detection algorithm.

Spleen injury identification and visualization

The cropped 3D images were used to develop the splenic injury classification model. We modified the block architecture to improve the interpretability of the reasoning process of the learned network. The output of the model was the probability of splenic injury.

Model performance was evaluated using the area under the receiver operating characteristic curve (AUROC), accuracy, sensitivity, specificity, positive predictive value ,and negative predictive value.

Being tested
Deep learning algorithm
Keywords
deep learning, artificial intelligence, spleen trauma, spleen injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep learning algorithmDiagnostic test

    A sequential two-stage 3D spleen injury detection framework to identify splenic injury in the CT scans

Study groups in NCT05643612
Study groupRoleWhat they receive
splenic injury groupWe retrospectively collected data from patients who underwent contrast-enhanced abdominal CT in the emergency department of Chang Gung Memorial Hospital, Linko, due to trauma and acute abdomen from Jul 2008 to Dec 2017. We identified 300 venous phase scans with splenic injury.
Receives: Diagnostic Test: Deep learning algorithm
control groupWe retrospectively collected data from patients who underwent contrast-enhanced abdominal CT in the emergency department of Chang Gung Memorial Hospital, Linko, due to trauma and acute abdomen from Jul 2008 to Dec 2017. We randomly selected 300 additional venous phase scans without splenic injury
Receives: Diagnostic Test: Deep learning algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy

    Diagnostic accuracy of the deep learning algorithm to detect splenic injury

    Measured: 3 days

Secondary outcomes (1)
  1. Comparison of difference backbone of algorithm

    The difference of diagnostic accuracy between different infrastructure of deep learning algorithm

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

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
Other
Time perspective
Retrospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05643612
Sponsor's protocol ID
SpleenTrNet
Status last verified
Nov 2022
First submitted
30 Nov 2022
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Because we extract the de-identified data from registry databank, we could not offer individual participant data.

Questions about this trial

What is this clinical trial studying?

An observational study of Spleen Injury and Machine Learning, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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