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RecruitingNCT06245954Updated Feb 10, 2025

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

An interventional study of simulated training and traditional bedside teaching in Transbronchial Lung Cryobiopsy, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Transbronchial Lung Cryobiopsy

Keywords

  • transbronchial lung cryobiopsy
  • standardized training
  • learning curve
  • bronchoscopist
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Standardized training group

    The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs

    Other: simulated training

  • Other
    Traditional teaching model group

    The bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC

    Other: traditional bedside teaching

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

06

What researchers measure

Primary outcomes

  1. Obtain pathologic quality assessment of specimens

    The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.

    Time frame: 1 month

  2. histopathological pattern diagnosis rate

    Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.

    Time frame: 1 month

  3. diagnostic rate of multidisciplinary discussions

    Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts

    Time frame: 1 month

Secondary outcomes

  1. Occurrence of short-term adverse events

    bleeding and pneumothorax occurred with 24 hours after TBLC, acute exacerbation of ILD and death occurred with 7 days after TBLC

    Time frame: 24 hours or 7 days

07

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06245954
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Gang Hou (Principal Investigator, China-Japan Friendship Hospital) — Principal investigator
First posted
Feb 7, 2024
Start date
Mar 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 10, 2025

Study contacts

Mingming Deng, MD
Contact
isdeng1017@163.com
86 18801336854

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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