The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases

Overview

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

Full Title of Study: “The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2020

Detailed Description

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.

Interventions

  • Procedure: Transbronchial Cryobiopsy
    • Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Arms, Groups and Cohorts

  • Sham Comparator: the freezing time of 3s
    • Transbronchial cryobiopsy in the freezing time of 3s
  • Experimental: the freezing time of 4s
    • Transbronchial cryobiopsy in the freezing time of 4s
  • Experimental: the freezing time of 5s
    • Transbronchial cryobiopsy in the freezing time of 5s
  • Experimental: the freezing time of 6s
    • Transbronchial cryobiopsy in the freezing time of 6s

Clinical Trial Outcome Measures

Primary Measures

  • Diagnotic yield
    • Time Frame: two weeks
    • Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy

Secondary Measures

  • Complication rate
    • Time Frame: one week
    • Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy

Participating in This Clinical Trial

Inclusion Criteria

1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. 2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed. Exclusion Criteria:

1. The radiological data indicates non-DPLD 2. The clinical examinations mentioned above are not completed. 3. The patient cannot endure or does not agree the procedure.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Institute of Respiratory Disease
  • Provider of Information About this Clinical Study
    • Principal Investigator: ShiYue Li, Director of the Respiratory department – Guangzhou Institute of Respiratory Disease
  • Overall Contact(s)
    • Xiaobo Chen, master, +8613751721744, xiaobo-win@163.com

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