Clinical trial NCT04661956: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnosis
Complication Rate
Keywords: Transbronchial Cryobiopsy
Diagnostic Yield
Safety
Pulmonary Periphral Nodule
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective multicenter random control trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnotic yield
timeFrame: six months
Secondary outcomes:
measure: Complication rate
timeFrame: one week
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: AnHui Chest Hospital
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Second Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Guangming New District People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital Of WuHan
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Hospital of Integrated Chinese & Western Medicine
state: Hubei
city: Changsha
country: China
facility: People's Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: XiangYa Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xi'an chest hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Huangzhou
country: China
facility: Zhejiang Provincial People' s Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, master
role: STUDY_CHAIR
References: