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.
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.
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.
- Conditions
- Spleen Injury, Machine Learning
- 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 group | Role | What they receive |
|---|---|---|
| splenic injury group | 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. We identified 300 venous phase scans with splenic injury. Receives: Diagnostic Test: Deep learning algorithm | |
| control group | 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. 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.
Diagnostic accuracy
Diagnostic accuracy of the deep learning algorithm to detect splenic injury
Measured: 3 days
Secondary outcomes (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.
- First posted9 Dec 2022
- Study start1 Feb 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spleen InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Hung Liao, Chang Gung Memorial Hospital
- Investigators
- Chien-Hung Liao, MD., Principal investigator, Chang Gung Memorial Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Three-dimensional Weakly Supervised Deep Learning Algorithm for Traumatic Splenic Injury Detection and Sequential Localization
- ClinicalTrials.gov ID
- NCT05643612
- Acronym / sponsor ID
- SpleenTrNet
- Conditions
- Spleen Injury, Machine Learning
- Keywords
- deep learning, artificial intelligence, spleen trauma, spleen injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| splenic injury group | – | Diagnostic Test: Deep learning algorithmWe 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. |
| control group | – | Diagnostic Test: Deep learning algorithmWe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- patients who underwent abdominal computed tomography in emergency department for trauma and acute abdominal survey from Jul 2008 to Dec 2017.
Key exclusion criteria (3 listed)
- poor quality images
- no contrast series of computed tomography images.
- images from other hospitals without proper evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep learning algorithmA sequential two-stage 3D spleen injury detection framework to identify splenic injury in the CT scans | Diagnostic test | control group, splenic injury group |
Primary outcome
Diagnostic accuracy
Time frame: 3 days
Diagnostic accuracy of the deep learning algorithm to detect splenic injury
1 secondary outcome
Comparison of difference backbone of algorithm
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No. Because we extract the de-identified data from registry databank, we could not offer individual participant data.
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Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hung Liao, MD. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
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.