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

NCT06245954 | Recruiting

• 1 other identifier: ZRJY2021-BJ08-03-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Transbronchial Lung Cryobiopsy

Keywords

transbronchial lung cryobiopsy; standardized training; learning curve; bronchoscopist

Outcome Measures

Primary Outcomes (3)

• 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

• histopathological pattern diagnosis rate

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

  1 month

• 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 Outcomes (1)

• Occurrence of short-term adverse events

  24 hours or 7 days

Study Arms (2)

Standardized training group

EXPERIMENTAL

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

Other: simulated training

Traditional teaching model group

OTHER

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

Other: traditional bedside teaching

Interventions

simulated training OTHER

Simulation training of bronchoscopists by means of simulators and extracorporeal lungs

Standardized training group

traditional bedside teaching OTHER

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

Traditional teaching model group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)