Pleural DiseasesNCT06423066
Developing a Machine Learning Model to Predict Pleural Adhesion Preoperatively Using Pleural Ultrasound
An observational study of Pleural Diseases and Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to investigate the accuracy of using pleural ultrasound (USP) to identify pleural adhesions in patients who plan to receive video-assisted thoracoscopic surgery. It employs three-dimensional convolutional neural network (3D-CNN) technology to process USP-related images and video data for machine… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Pleural Diseases, Lung Cancer, Machine Learning
- What is being tested?
- Pleural ultrasound
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Mar 2026
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who plan to accept VATS surgery in Peking Union Medical college Hospital, and agree to perform preoperative plerual ultrasound examination.
Who may be able to join
- 1. Patients who plan to accept VATS surgery.
Who cannot join
- Patients who can not obtain detailed clinical information;
- Patients or their family members who can not understand the conditions and objectives of the study or refuse to participate in the study;
- Patients with conditions affecting observation, such as skin lesions, infections, or scars in the area of the chest wall to be examined.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xuehan Gao, 18801341299, gaoxh1299@163.com
Yuanjing Gao, MD, 16619765781, gaoxh1299@163.com
About this study
Official title: Developing a Machine Learning Model to Predict Pleural Adhesion Preoperatively Using Pleural Ultrasound: A Prospective Observational Study
This study aims to investigate the accuracy of using pleural ultrasound (USP) to identify pleural adhesions in patients who plan to receive video-assisted thoracoscopic surgery. It employs three-dimensional convolutional neural network (3D-CNN) technology to process USP-related images and video data for machine learning, and to establish a diagnostic model for identifying pleural adhesions using 3D-CNN-USP. The study will determine the sensitivity, specificity, positive predictive value, and negative predictive value of 3D-CNN-USP in identifying pleural adhesions. Additionally, it will explore the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions in VATS, thereby supporting the implementation of day surgery in thoracic surgery and ultimately serving clinical practice.
Read the detailed description
Lung cancer is currently the leading cause of death from malignant tumors worldwide. Surgery is the primary treatment method for lung cancer, and breakthroughs in thoracic surgical techniques play a crucial role in the diagnosis and treatment of lung cancer. Medical ultrasound technology, due to its non-invasive, flexible, convenient, and economical characteristics, is widely used in clinical practice. With the advancement of ultrasound technology and the need to address clinical challenges, ultrasound imaging technology has seen new developments in the field of thoracoscopic surgery.
In the era of minimally invasive surgery, intraoperative pleural adhesions are one of the main factors affecting the implementation of video-assisted thoracoscopic surgery (VATS). Especially under the concept of enhanced recovery after surgery (ERAS), the day surgery model for VATS has gradually taken shape. However, pleural adhesions significantly increase intraoperative trauma and prolong hospital stays. Additionally, pleural adhesions increase the risk of lung injury during VATS and, in severe cases, may hinder access to the pleural space, necessitating conversion to open thoracotomy. Pleural adhesions increase intraoperative time and morbidity in thoracic surgery due to poor visibility, bleeding, and lung and vascular injuries. The presence, location, and degree of pleural adhesions are useful for determining the initial port placement or choosing between open or VATS approaches. Therefore, accurately predicting the presence and specific location of pleural adhesions preoperatively is crucial for the development of day surgery under thoracic ERAS, ensuring the safety and efficiency of future VATS day surgeries.
Previous studies have shown that chest CT is difficult to predict pleural adhesions, with a sensitivity of only 72% and a sensitivity of only 46% for determining adhesions at specific locations. In contrast, ultrasonography of the pleura (USP) can dynamically display pleural sliding and adhesions with surrounding lung tissue, and has real-time monitoring capabilities based on movement, providing unique advantages for detecting pleural adhesions. Preoperative prediction of pleural adhesions using USP has significant application value. Studies have already demonstrated the advantages of using transthoracic pleural ultrasound to identify pleural adhesions. Nicola et al. conducted 1,192 ultrasounds to predict pleural adhesions, confirming 1,124 positive cases and 68 negative cases, with a sensitivity of 80.6%, specificity of 96.1%, positive predictive value of 73.2%, and negative predictive value of 97.4%. However, there are still some issues with using USP to predict pleural adhesions. Physicians who can identify pleural adhesions need to be trained in lung ultrasound, and ultrasound examination and interpretation are skill-dependent techniques. The burden of training thoracic ultrasound physicians remains a clinical challenge.
Three-dimensional convolutional neural network (3D-CNN) technology is an emerging technology in the field of artificial intelligence and machine learning. Unlike traditional convolutional neural networks (CNN), 3D-CNN can process three-dimensional data that includes a time dimension, making it suitable for analyzing the real-time dynamic image features of ultrasound images. This technology holds promise for developing a machine learning model to interpret USP images, potentially replacing physician interpretation and improving the accuracy of USP in identifying pleural adhesions.
In summary, this study intends to use USP for preoperative identification of pleural adhesions in patients scheduled for VATS surgery. It aims to investigate the accuracy of USP in predicting intraoperative pleural adhesions and to develop a diagnostic model using 3D-CNN technology to process USP-related images and video data for machine learning. The study will explore the sensitivity, specificity, positive predictive value, and negative predictive value of the 3D-CNN-USP model in identifying pleural adhesions. Additionally, it will examine the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions to support the implementation of day surgery in thoracic surgery.
- Conditions
- Pleural Diseases, Lung Cancer, Machine Learning
- Being tested
- Pleural ultrasound
- Keywords
- pleural adhesion, 3D-CNN, machine learning, VATS
- Medical subject headings
- Pleural Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural ultrasoundDiagnostic test
Patients who examine pleural ultrasound preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Pleural ultrasound group | Patients who accept pleural ultrasound preoperatively. Receives: Diagnostic Test: Pleural ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of three-dimensional convolutional neural network (3D-CNN) in identifying pleural adhesions using pleural ultrasound (USP). The sensitivity value ranges from 0 to 100, with higher values indicating greater sensitivity.
Measured: From enrollment to the end of surgery.
Secondary outcomes (3)
Specificity
Specificity off 3D-CNN in identifying pleural adhesions using USP. The specificity value ranges from 0 to 100, with higher values indicating greater specificity.
Measured: From enrollment to the end of surgery.
Positive predictive value
Positive predictive value (PPV) of 3D-CNN in identifying pleural adhesions using USP. PPV is calculated by dividing the number of true positive results by the total number of positive test results. A higher PPV means that the test is more reliable in correctly identifying those with the condition.
Measured: From enrollment to the end of surgery.
Negative predictive value
Negative predictive value (NPV) of 3D-CNN in identifying pleural adhesions using USP. NPV is calculated by dividing the number of true negative results by the total number of negative test results. A higher NPV means that the test is more reliable in correctly identifying those without the condition.
Measured: From enrollment to the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehan Gao, Peking Union Medical College Hospital
- Investigators
- Shanqing Li, PhD, and MD, Study director, Peking Union Medical College HospitalQingli Zhu, PhD, and MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423066
- Sponsor's protocol ID
- USPDPA01
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of this study will be used in future analyses and be published in academic article.
Publications
Mason AC, Miller BH, Krasna MJ, White CS. Accuracy of CT for the detection of pleural adhesions: correlation with video-assisted thoracoscopic surgery. Chest. 1999 Feb;115(2):423-7. doi: 10.1378/chest.115.2.423.
PubMed 10027442Cassanelli N, Caroli G, Dolci G, Dell'Amore A, Luciano G, Bini A, Stella F. Accuracy of transthoracic ultrasound for the detection of pleural adhesions. Eur J Cardiothorac Surg. 2012 Nov;42(5):813-8; discussion 818. doi: 10.1093/ejcts/ezs144. Epub 2012 Apr 19.
PubMed 22518039
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Machine Learning Model to Predict Pleural Adhesion Preoperatively Using Pleural Ultrasound: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06423066
- Acronym / sponsor ID
- USPDPA01
- Conditions
- Pleural Diseases, Lung Cancer, Machine Learning
- Keywords
- pleural adhesion, 3D-CNN, machine learning, VATS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 May 2024 (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.
This study aims to investigate the accuracy of using pleural ultrasound (USP) to identify pleural adhesions in patients who plan to receive video-assisted thoracoscopic surgery. It employs three-dimensional convolutional neural network (3D-CNN) technology to process USP-related images and video data for machine learning, and to establish a diagnostic model for identifying pleural adhesions using 3D-CNN-USP. The study will determine the sensitivity, specificity, positive predictive value, and negative predictive value of 3D-CNN-USP in identifying pleural adhesions. Additionally, it will explore the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions in VATS, thereby supporting the implementation of day surgery in thoracic surgery and ultimately serving clinical practice.
Detailed description
Lung cancer is currently the leading cause of death from malignant tumors worldwide. Surgery is the primary treatment method for lung cancer, and breakthroughs in thoracic surgical techniques play a crucial role in the diagnosis and treatment of lung cancer. Medical ultrasound technology, due to its non-invasive, flexible, convenient, and economical characteristics, is widely used in clinical practice. With the advancement of ultrasound technology and the need to address clinical challenges, ultrasound imaging technology has seen new developments in the field of thoracoscopic surgery.
In the era of minimally invasive surgery, intraoperative pleural adhesions are one of the main factors affecting the implementation of video-assisted thoracoscopic surgery (VATS). Especially under the concept of enhanced recovery after surgery (ERAS), the day surgery model for VATS has gradually taken shape. However, pleural adhesions significantly increase intraoperative trauma and prolong hospital stays. Additionally, pleural adhesions increase the risk of lung injury during VATS and, in severe cases, may hinder access to the pleural space, necessitating conversion to open thoracotomy. Pleural adhesions increase intraoperative time and morbidity in thoracic surgery due to poor visibility, bleeding, and lung and vascular injuries. The presence, location, and degree of pleural adhesions are useful for determining the initial port placement or choosing between open or VATS approaches. Therefore, accurately predicting the presence and specific location of pleural adhesions preoperatively is crucial for the development of day surgery under thoracic ERAS, ensuring the safety and efficiency of future VATS day surgeries.
Previous studies have shown that chest CT is difficult to predict pleural adhesions, with a sensitivity of only 72% and a sensitivity of only 46% for determining adhesions at specific locations. In contrast, ultrasonography of the pleura (USP) can dynamically display pleural sliding and adhesions with surrounding lung tissue, and has real-time monitoring capabilities based on movement, providing unique advantages for detecting pleural adhesions. Preoperative prediction of pleural adhesions using USP has significant application value. Studies have already demonstrated the advantages of using transthoracic pleural ultrasound to identify pleural adhesions. Nicola et al. conducted 1,192 ultrasounds to predict pleural adhesions, confirming 1,124 positive cases and 68 negative cases, with a sensitivity of 80.6%, specificity of 96.1%, positive predictive value of 73.2%, and negative predictive value of 97.4%. However, there are still some issues with using USP to predict pleural adhesions. Physicians who can identify pleural adhesions need to be trained in lung ultrasound, and ultrasound examination and interpretation are skill-dependent techniques. The burden of training thoracic ultrasound physicians remains a clinical challenge.
Three-dimensional convolutional neural network (3D-CNN) technology is an emerging technology in the field of artificial intelligence and machine learning. Unlike traditional convolutional neural networks (CNN), 3D-CNN can process three-dimensional data that includes a time dimension, making it suitable for analyzing the real-time dynamic image features of ultrasound images. This technology holds promise for developing a machine learning model to interpret USP images, potentially replacing physician interpretation and improving the accuracy of USP in identifying pleural adhesions.
In summary, this study intends to use USP for preoperative identification of pleural adhesions in patients scheduled for VATS surgery. It aims to investigate the accuracy of USP in predicting intraoperative pleural adhesions and to develop a diagnostic model using 3D-CNN technology to process USP-related images and video data for machine learning. The study will explore the sensitivity, specificity, positive predictive value, and negative predictive value of the 3D-CNN-USP model in identifying pleural adhesions. Additionally, it will examine the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions to support the implementation of day surgery in thoracic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pleural ultrasound group | – | Diagnostic Test: Pleural ultrasoundPatients who accept pleural ultrasound preoperatively. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who plan to accept VATS surgery in Peking Union Medical college Hospital, and agree to perform preoperative plerual ultrasound examination.
Key inclusion criteria (1 listed)
- 1. Patients who plan to accept VATS surgery.
Key exclusion criteria (3 listed)
- Patients who can not obtain detailed clinical information;
- Patients or their family members who can not understand the conditions and objectives of the study or refuse to participate in the study;
- Patients with conditions affecting observation, such as skin lesions, infections, or scars in the area of the chest wall to be examined.
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 |
|---|---|---|
| Pleural ultrasoundPatients who examine pleural ultrasound preoperatively. | Diagnostic test | Pleural ultrasound group |
Primary outcome
Sensitivity
Time frame: From enrollment to the end of surgery.
Sensitivity of three-dimensional convolutional neural network (3D-CNN) in identifying pleural adhesions using pleural ultrasound (USP). The sensitivity value ranges from 0 to 100, with higher values indicating greater sensitivity.
3 secondary outcomes
Specificity
Time frame: From enrollment to the end of surgery.
Positive predictive value
Time frame: From enrollment to the end of surgery.
Negative predictive value
Time frame: From enrollment to the end of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Results publication: PubMed 10027442Mason AC, Miller BH, Krasna MJ, White CS. Accuracy of CT for the detection of pleural adhesions: correlation with video-assisted thoracoscopic surgery. Chest. 1999 Feb;115(2):423-7. doi: 10.1378/chest.115.2.423.
- Results publication: PubMed 22518039Cassanelli N, Caroli G, Dolci G, Dell'Amore A, Luciano G, Bini A, Stella F. Accuracy of transthoracic ultrasound for the detection of pleural adhesions. Eur J Cardiothorac Surg. 2012 Nov;42(5):813-8; discussion 818. doi: 10.1093/ejcts/ezs144. Epub 2012 Apr 19.
- Individual participant dataSharing planned: No. The data of this study will be used in future analyses and be published in academic article.
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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.
Shanqing Li, PhD, and MD study director
Peking Union Medical College Hospital
Qingli Zhu, PhD, and MD principal investigator
Peking Union Medical College 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 Pleural Diseases and Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehan Gao, MD (18801341299, gaoxh1299@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: From enrollment to the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423066, which also lists 2 linked publications.
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 21 May 2024.