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

Not Applicable
Conditions
Complication Rate
Diagnosis
Interventions
Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
Registration Number
NCT04661956
Lead Sponsor
ShiYue Li
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
300
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Transbronchial cryobiopsyTransbronchial cryobiopsy/Transbronchial lung biopsy (forcep)Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule
Transbronchial lung biopsyTransbronchial cryobiopsy/Transbronchial lung biopsy (forcep)Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule
Primary Outcome Measures
NameTimeMethod
Diagnotic yieldsix months

Percentage of definitive pathological diagnosis by transbronchial cryobiopsy

Secondary Outcome Measures
NameTimeMethod
Complication rateone week

Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention

Trial Locations

Locations (24)

Xiamen Second Hospital

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Xiamen, Fujian, China

Lanzhou University Second Hospital

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Lanzhou, Gansu, China

The First Hospital of Lanzhou University

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Lanzhou, Gansu, China

Guangdong General Hospital

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Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital

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Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

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Shenzhen, Guangdong, China

People's Hospital of Hunan Province

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Changsha, Hunan, China

Xi'an chest hospital

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Xi'an, Shanxi, China

Shanghai Chest Hospital

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Shanghai, Shanghai, China

First Affiliated Hospital of Xi'an Jiaotong University

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Xi'an, Shanxi, China

Hubei Provincial Hospital of Integrated Chinese & Western Medicine

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Wuhan, Hubei, China

XiangYa Hospital Central South University

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Changsha, Hunan, China

Shenzhen Guangming New District People's Hospital

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Shenzhen, Guangdong, China

The First Affiliated Hospital of Nanchang University

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Nanchang, Jiangxi, China

The First Hospital of Jiaxing

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Jiaxing, Zhejiang, China

Henan Provincial People's Hospital

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Zhengzhou, Henan, China

The First Affiliated Hospital of Bengbu Medical College

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Bengbu, Anhui, China

AnHui Chest Hospital

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Hefei, Anhui, China

China-Japan Friendship Hospital

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Beijing, Beijing, China

The Central Hospital Of WuHan

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Wuhan, Hubei, China

Shanghai Pulmonary Hospital

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Shanghai, Shanghai, China

Zhejiang Provincial People' s Hospital

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Huangzhou, Zhejiang, China

The First Affiliated Hospital Sun Yat-sen University

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Guangzhou, Guangdong, China

Zhongda Hospital Southeast University

πŸ‡¨πŸ‡³

Nanjing, Jiangsu, China

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