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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Xuehan Gao, MD contact

18801341299

gaoxh1299@163.com

Yuanjing Gao, MD contact

16619765781

yuanjing1997@gmail.com

China1 site
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Xuehan Gao, 18801341299, gaoxh1299@163.com

    Yuanjing Gao, MD, 16619765781, gaoxh1299@163.com

Other trials in China

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.

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 groups in NCT06423066
Study groupRoleWhat they receive
Pleural ultrasound groupPatients 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  1. First posted21 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Mar 2026 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
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 10027442
  • Cassanelli 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

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; AzTrials last refreshed its copy on 26 Oct 2026.

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