The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy

Not Applicable

Recruiting

• Conditions: Transbronchial Lung Cryobiopsy
• Interventions: Other: simulated training; Other: traditional bedside teaching

• Registration Number: NCT06245954
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized training group	simulated training	The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs
Traditional teaching model group	traditional bedside teaching	The bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC

Primary Outcome Measures

Name	Time	Method
Obtain pathologic quality assessment of specimens	1 month	The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
histopathological pattern diagnosis rate	1 month	Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
diagnostic rate of multidisciplinary discussions	1 month	Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts

Secondary Outcome Measures

Name	Time	Method
Occurrence of short-term adverse events	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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China