Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05774730
• Other study ID #: 2022-NHLHCRF-LX-01-0202-2
• Status: Not yet recruiting
• Start date: March 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.

Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria

• FEV1 = 45% pred and FEV1/FVC<70%

• TLC>100% pred and RV>175% pred

• CAT=18

• >50% of emphysema destruction

• Smoking prohibition>6 months

• Sign the informed consent form

Exclusion Criteria:

• PaCO2>8.0 kPa, or PaO2<6.0 kPa

• 6-minute walking test<160m

• Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases

• Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment

• Previous lobectomy, LVRS or lung transplantation

• LVEF<45% and or RVSP>50mmHg

• Anticoagulant therapy that cannot be stopped before surgery

• The patient has obvious immune deficiency

• Participated in other lung drug studies within 30 days before this study

• Pulmonary nodules requiring intervention

• Any disease or condition that interferes with the completion of the initial or subsequent assessment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Emphysema quantitative analysis software based on chest image AI technology
The participants would undergo lung CT, and the integrity of interlobar fissure will be quantitatively analyses by software based on chest image AI technology.
• artificial analysis of chest image
The participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses.

Procedure:
• imported Chartis detection system
The participants would undergo imported Chartis detection system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	1 month after bronchoscopic valve lung volume reduction
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	3 months after bronchoscopic valve lung volume reduction
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	6 months after bronchoscopic valve lung volume reduction
Primary	the integrity of interlobar fissure	Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system	Before bronchoscopic valve lung volume reduction