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The Diagnostic Yield and Safe...

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

NCT ID: NCT04661956

Last Updated: 2021-10-15

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

UNKNOWN

Clinical Phase

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-06-15

Brief Summary

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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

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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.

Conditions

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Diagnosis Complication Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a prospective multicenter random control trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transbronchial cryobiopsy

Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule

Group Type EXPERIMENTAL

Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Intervention Type PROCEDURE

Transbronchial lung biopsy by cryoprobe or by forcep

Transbronchial lung biopsy

Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule

Group Type OTHER

Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Intervention Type PROCEDURE

Transbronchial lung biopsy by cryoprobe or by forcep

Interventions

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Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Transbronchial lung biopsy by cryoprobe or by forcep

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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ShiYue Li

Guangzhou Institute of Respiratory Disease

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shiyue Li, master

Role: STUDY_CHAIR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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