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

Transbronchial Lung Cryobiopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245954
• Other study ID #: ZRJY2021-BJ08-03-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Transbronchial Lung Cryobiopsy

Intervention

Other:
• simulated training
Simulation training of bronchoscopists by means of simulators and extracorporeal lungs
• traditional bedside teaching
TBLC training for bronchoscopists through traditional lectures, hands-on demonstrations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtain pathologic quality assessment of specimens	The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.	1 month
Primary	histopathological pattern diagnosis rate	Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.	1 month
Primary	diagnostic rate of multidisciplinary discussions	Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts	1 month
Secondary	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	24 hours or 7 days