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

Not Applicable

Recruiting

• Conditions: Transbronchial Lung Cryobiopsy

• 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

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