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

Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06245954

Enrollment

Registered

2024-02-07

Start date

2024-03-01

Completion date

2026-12-31

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transbronchial Lung Cryobiopsy

Keywords

transbronchial lung cryobiopsy, standardized training, learning curve, bronchoscopist

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.

Interventions

OTHERsimulated training

Simulation training of bronchoscopists by means of simulators and extracorporeal lungs

OTHERtraditional bedside teaching

TBLC training for bronchoscopists through traditional lectures, hands-on demonstrations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactMingming Deng, MD

isdeng1017@163.com86 18801336854

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026