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

NCT ID: NCT06245954

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Transbronchial Lung Cryobiopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standardized training group

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

Group Type EXPERIMENTAL

simulated training

Intervention Type OTHER

Simulation training of bronchoscopists by means of simulators and extracorporeal lungs

Traditional teaching model group

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

Group Type OTHER

traditional bedside teaching

Intervention Type OTHER

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

Interventions

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simulated training

Simulation training of bronchoscopists by means of simulators and extracorporeal lungs

Intervention Type OTHER

traditional bedside teaching

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingming Deng, MD

Role: CONTACT

86 18801336854

Facility Contacts

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Mingming Deng

Role: primary

18801336854

Other Identifiers

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ZRJY2021-BJ08-03-02

Identifier Type: -

Identifier Source: org_study_id

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