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Clinical Trials/NCT05774730
NCT05774730
Not yet recruiting
Not Applicable

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

China-Japan Friendship Hospital0 sites40 target enrollmentMarch 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
China-Japan Friendship Hospital
Enrollment
40
Primary Endpoint
Therapeutic effect of lung volume reduction surgery
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gang Hou

Principal Investigator

China-Japan Friendship Hospital

Eligibility Criteria

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
  • \>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

Outcomes

Primary Outcomes

Therapeutic effect of lung volume reduction surgery

Time Frame: 6 months after bronchoscopic valve lung volume reduction

Lung CT

the integrity of interlobar fissure

Time Frame: Before bronchoscopic valve lung volume reduction

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

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