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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule

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ClinicalTrials.gov Identifier: NCT04661956
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
ShiYue Li, Guangzhou Institute of Respiratory Disease

Study Description
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Brief Summary:
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

Condition or disease Intervention/treatment Phase
Diagnosis Complication Rate Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) Not Applicable

Detailed Description:
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a prospective multicenter random control trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Transbronchial cryobiopsy
Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule
 Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
Transbronchial lung biopsy by cryoprobe or by forcep
Transbronchial lung biopsy
Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule
 Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
Transbronchial lung biopsy by cryoprobe or by forcep


Outcome Measures
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Primary Outcome Measures :
  1. Diagnotic yield [ Time Frame: six months ]
    Percentage of definitive pathological diagnosis by transbronchial cryobiopsy


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: one week ]
    Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
  2. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
  3. The Pulmonary Periphral Nodule can be detected by radial-EBUS
  4. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
  5. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.

Exclusion Criteria:

  1. The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
  2. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
  3. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661956


Contacts
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Contact: Xiaobo Chen, Doctor +8613751721744 xiaobo-win@163.com
Contact: Shiyue Li, master 8620-83062896 lishiyue@188.com

Locations
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Sponsors and Collaborators
ShiYue Li
Investigators
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Study Chair: Shiyue Li, master The First Affiliated Hospital of Guangzhou Medical University
More Information
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Responsible Party: ShiYue Li, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT04661956    
Other Study ID Numbers: 20200914
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShiYue Li, Guangzhou Institute of Respiratory Disease:
Transbronchial Cryobiopsy
Diagnostic Yield
Safety
Pulmonary Periphral Nodule