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

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05774730
Collaborator
(none)
40
Enrollment
21.2
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Emphysema quantitative analysis software based on chest image AI technology
  • Other: artificial analysis of chest image
  • Procedure: imported Chartis detection system

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology
Anticipated Study Start Date :
Mar 26, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Emphysema quantitative analysis softwarebased on chest image AI technology

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

Other: artificial analysis of chest image
The participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses.
imported Chartis detection system

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

Outcome Measures

Primary Outcome Measures

  1. Therapeutic effect of lung volume reduction surgery [1 month after bronchoscopic valve lung volume reduction]

    Lung CT

  2. Therapeutic effect of lung volume reduction surgery [3 months after bronchoscopic valve lung volume reduction]

    Lung CT

  3. Therapeutic effect of lung volume reduction surgery [6 months after bronchoscopic valve lung volume reduction]

    Lung CT

  4. the integrity of interlobar fissure [Before bronchoscopic valve lung volume reduction]

    Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gang Hou, Principal Investigator, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05774730
Other Study ID Numbers:
  • 2022-NHLHCRF-LX-01-0202-2
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Mar 21, 2023