China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
Recruiting
NCT Number: NCT06245954
The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy
The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥18 years
- suspected ILD.
- ≤3 months since HRCT
- Forced vital capacity (FVC) ≥50% of predicted value
- Diffused lung carbon monoxide (DLCO) ≥35% predicted value
- Echocardiography ≤ 12 months
- Estimated pulmonary artery systolic pressure ≤40 mmHg
- Body mass index (BMI) ≤35 kg/m2
- Patient consent for experimentation
Exclusion criteria
- Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
- Patients refused to participate in the experiment
Treatment and study plan
simulated training
OtherSimulation training of bronchoscopists by means of simulators and extracorporeal lungs
traditional bedside teaching
OtherTBLC training for bronchoscopists through traditional lectures, hands-on demonstrations
Primary outcomes
-
Obtain pathologic quality assessment of specimens
Time frame: 1 month
The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
-
histopathological pattern diagnosis rate
Time frame: 1 month
Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
-
diagnostic rate of multidisciplinary discussions
Time frame: 1 month
Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts
Secondary outcomes
-
Occurrence of short-term adverse events
Time frame: 24 hours or 7 days
bleeding and pneumothorax occurred with 24 hours after TBLC, acute exacerbation of ILD and death occurred with 7 days after TBLC
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
China-Japan Friendship Hospital
Other
Registry information
Official study title
Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 7, 2024
- Registry last updated
- Feb 10, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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