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

Diagnosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661956
• Other study ID #: 20200914
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: October 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Xiaobo Chen, Doctor
• Phone: +8613751721744
• Email: xiaobo-win[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication Rate
• Diagnosis

Intervention

Procedure:
• Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
Transbronchial lung biopsy by cryoprobe or by forcep

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	People's Hospital of Hunan Province	Changsha	Hunan
China	XiangYa Hospital Central South University	Changsha	Hunan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	AnHui Chest Hospital	Hefei	Anhui
China	Zhejiang Provincial People' s Hospital	Huangzhou	Zhejiang
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Guangming New District People's Hospital	Shenzhen	Guangdong
China	Hubei Provincial Hospital of Integrated Chinese & Western Medicine	Wuhan	Hubei
China	The Central Hospital Of WuHan	Wuhan	Hubei
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an chest hospital	Xi'an	Shanxi
China	Xiamen Second Hospital	Xiamen	Fujian
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
ShiYue Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnotic yield	Percentage of definitive pathological diagnosis by transbronchial cryobiopsy	six months
Secondary	Complication rate	Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention	one week