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

ShiYue Li24 sites in 1 country300 target enrollmentDecember 15, 2020

ConditionsDiagnosis Complication Rate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diagnosis
Sponsor: ShiYue Li
Enrollment: 300
Locations: 24
Primary Endpoint: Diagnotic yield
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2020

End Date

June 15, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ShiYue Li

Responsible Party

Sponsor Investigator

Principal Investigator

ShiYue Li

Guangzhou Institute of Respiratory Disease

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
•The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
•The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure