The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases

NCT ID: NCT03704233

Last Updated: 2019-03-07

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

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-10-20

Brief Summary

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The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.

Detailed Description

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Conditions

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Diffuse Parenchymal Lung Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cryobiopsy

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

Transbronchial cryobiopsy

Intervention Type PROCEDURE

Transbronchial cryobiopsy procedure

Interventions

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Transbronchial cryobiopsy

Transbronchial cryobiopsy procedure

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.
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 Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyue Li

Role: STUDY_CHAIR

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Locations

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AnHui Chest Hospital

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Xiamen Second Hospital

Xiamen, Fujian, China

Site Status NOT_YET_RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

the First Affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen Guangming New District People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Affiliated Zhongshan Hospital of Guangdong Medical University

Zhongshan, Guangdong, China

Site Status NOT_YET_RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The Central Hospital Of WuHan

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Department of Respiratory and Critical Care Medicine,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

People's Hospital of Hunan Province

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

XiangYa Hospital Central South University

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Dalian Muncipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

The First Hospital of China Medical University

Shengyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Xi'an chest hospital

Xi’an, Shanxi, China

Site Status RECRUITING

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

MianYang Central Hospital

Mianyang, Sichuan, China

Site Status RECRUITING

China Medical University Hospital

Taizhong, Taiwan, China

Site Status NOT_YET_RECRUITING

The first Hospital of Jiaxing

Jiaxing, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shiyue Li

Role: CONTACT

8620-83062896

Xiaobo Chen

Role: CONTACT

8620-83062885

Facility Contacts

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Liping Lv, BD

Role: primary

13956954712

Fei Tang, MD

Role: backup

13505696936

Xiaoping Wang, PhD

Role: primary

18600569233

Shuliang Guo, PhD

Role: primary

023-89012097

Yishi Li, MD

Role: backup

023-89012692

Ming Yao Ke, BD

Role: primary

13860166866

Rui Huang, BD

Role: backup

15392037355

Jing Li, PhD

Role: primary

13825009393

Wenfang Chen, BD

Role: backup

17701966969

Huai Liao, MD

Role: primary

020-87755766-8171

Xinyan Huang, PhD

Role: backup

020-87755766-8171

Shiyue Li, MD

Role: primary

8620-83062896

Xiaobo Chen, MD

Role: backup

8620-83062885

Lai Yu Liu, PhD

Role: primary

13632102245

Wen Qi Huang, MD

Role: backup

13712920984

Ping Xu, PhD

Role: primary

0755-83923333

WD Song, PhD

Role: backup

0755-83923333

Fa Long, MD

Role: primary

13651472098

Peng Fu, BD

Role: backup

15989380761

Hong Mei Zhou, BD

Role: primary

13822715685

Xiaoju Zhang, PhD

Role: primary

0371-65580653

Quncheng Zhang, MD

Role: backup

0371-65580330

Yi Hu, MD

Role: primary

13995618974

Wen Yin, MD

Role: backup

15827232797

Jian Ping Zhao, PhD

Role: primary

02783663615

Peng Zuo, MD

Role: backup

02783663617

Zhiguang Liu, MD

Role: primary

073183928074

Wei Liu, PhD

Role: backup

073183920874

Hua Ping Yang, PhD

Role: primary

13973129956

Chun Fang Liu, MD

Role: primary

13804241131‬

Gang Hou, PhD

Role: primary

13840065481

Jiayuan Sun, PhD

Role: primary

021-22201512

Zheng Xiaoxuan, MD

Role: backup

021-22201512

Hao Wang, MD

Role: primary

13817624060

Tang Xiao Ming, PhD

Role: primary

13774269509

Yu Zheng, MD

Role: backup

13817846612

Yong Zhou, MD

Role: primary

02962500170

Chao Ruan, BD

Role: backup

02962500170

Feng Ming Luo, PhD

Role: primary

18980601355

Dan Liu, PhD

Role: backup

028-85422580

You Lv Wu, BD

Role: primary

13778138872

Chih-yen Tu, PhD

Role: primary

886-4-22052121-3483

Chia-Hung Chen, PhD

Role: backup

886-4-22052121-3483

Feng Tao, BD

Role: primary

0573-82082937

Na Li, MD

Role: backup

0573-82082937

References

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Chen X, Li J, Luo F, Tao F, Zhang X, Wu Y, Xu P, Ke M, Long F, Liu L, Lv L, Liao H, Gu Y, Liu Z, Tan X, Guo S, Hu Y, Yang H, Zhou Y, Zhou H, Ye Y, Chen D, Li S. The application of transbronchial cryobiopsy in interstitial lung disease: a prospective, multicenter, real-world study. Ann Transl Med. 2021 Nov;9(22):1645. doi: 10.21037/atm-21-3461.

Reference Type DERIVED
PMID: 34988154 (View on PubMed)

Other Identifiers

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2018-03-13

Identifier Type: -

Identifier Source: org_study_id

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