The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule
1 other identifier
interventional
300
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedOctober 15, 2021
October 1, 2021
1.5 years
October 26, 2020
October 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy
six months
Secondary Outcomes (1)
Complication rate
one week
Study Arms (2)
Transbronchial cryobiopsy
EXPERIMENTALTransbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule
Transbronchial lung biopsy
OTHERTransbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule
Interventions
Transbronchial lung biopsy by cryoprobe or by forcep
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ShiYue Lilead
Study Sites (24)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
AnHui Chest Hospital
Hefei, Anhui, 230003, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Xiamen Second Hospital
Xiamen, Fujian, 361021, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730099, China
Guangdong General Hospital
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Shenzhen Guangming New District People's Hospital
Shenzhen, Guangdong, 518106, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The Central Hospital Of WuHan
Wuhan, Hubei, 430014, China
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan, Hubei, 430015, China
People's Hospital of Hunan Province
Changsha, Hunan, 410005, China
XiangYa Hospital Central South University
Changsha, Hunan, 410008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Xi'an chest hospital
Xi’an, Shanxi, 710010, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Zhejiang Provincial People' s Hospital
Huangzhou, Zhejiang, 310014, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shiyue Li, master
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Guangzhou Institute of Respiratory Disease
Study Record Dates
First Submitted
October 26, 2020
First Posted
December 10, 2020
Study Start
December 15, 2020
Primary Completion
June 15, 2022
Study Completion
June 15, 2022
Last Updated
October 15, 2021
Record last verified: 2021-10