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

January 30, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized training group
The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs
Other: simulated training
Simulation training of bronchoscopists by means of simulators and extracorporeal lungs
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
TBLC training for bronchoscopists through traditional lectures, hands-on demonstrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtain pathologic quality assessment of specimens
Time Frame: 1 month
The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
1 month
histopathological pattern diagnosis rate
Time Frame: 1 month
Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
1 month
diagnostic rate of multidisciplinary discussions
Time Frame: 1 month
Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of short-term adverse events
Time Frame: 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
24 hours or 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZRJY2021-BJ08-03-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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