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

NCT ID: NCT03927235

Last Updated: 2019-05-30

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2020-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Transbronchial Cryobiopsy Freezing Time Diagnostic Yield Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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the freezing time of 3s

Transbronchial cryobiopsy in the freezing time of 3s

Group Type SHAM_COMPARATOR

Transbronchial Cryobiopsy

Intervention Type PROCEDURE

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

the freezing time of 4s

Transbronchial cryobiopsy in the freezing time of 4s

Group Type EXPERIMENTAL

Transbronchial Cryobiopsy

Intervention Type PROCEDURE

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

the freezing time of 5s

Transbronchial cryobiopsy in the freezing time of 5s

Group Type EXPERIMENTAL

Transbronchial Cryobiopsy

Intervention Type PROCEDURE

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

the freezing time of 6s

Transbronchial cryobiopsy in the freezing time of 6s

Group Type EXPERIMENTAL

Transbronchial Cryobiopsy

Intervention Type PROCEDURE

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Interventions

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Transbronchial Cryobiopsy

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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ShiYue Li

Director of the Respiratory department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaobo Chen, master

Role: CONTACT

+8613751721744

Shiyue Li, master

Role: CONTACT

+8613902233925

Facility Contacts

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Shiyue Li, professor

Role: primary

13902233925

Yao Yao, Dr

Role: backup

18826401822

Other Identifiers

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2018-3-30

Identifier Type: -

Identifier Source: org_study_id

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