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

Sponsor
ShiYue Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT04661956
Collaborator
(none)
300
Enrollment
24
Locations
2
Arms
18
Anticipated Duration (Months)
12.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a prospective multicenter random control triala prospective multicenter random control trial
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jun 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transbronchial cryobiopsy

Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule

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

Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule

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

Outcome Measures

Primary Outcome Measures

  1. Diagnotic yield [six months]

    Percentage of definitive pathological diagnosis by transbronchial cryobiopsy

Secondary Outcome Measures

  1. Complication rate [one week]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004
2 AnHui Chest Hospital Hefei Anhui China 230003
3 China-Japan Friendship Hospital Beijing Beijing China 100029
4 Xiamen Second Hospital Xiamen Fujian China 361021
5 Lanzhou University Second Hospital Lanzhou Gansu China 730030
6 The First Hospital of Lanzhou University Lanzhou Gansu China 730099
7 Guangdong General Hospital Guangzhou Guangdong China 510000
8 The First Affiliated Hospital Sun Yat-sen University Guangzhou Guangdong China 510080
9 Southern Medical University Nanfang Hospital Guangzhou Guangdong China 510515
10 Peking University Shenzhen Hospital Shenzhen Guangdong China 518036
11 Shenzhen Guangming New District People's Hospital Shenzhen Guangdong China 518106
12 Henan Provincial People's Hospital Zhengzhou Henan China 450003
13 The Central Hospital Of WuHan Wuhan Hubei China 430014
14 Hubei Provincial Hospital of Integrated Chinese & Western Medicine Wuhan Hubei China 430015
15 People's Hospital of Hunan Province Changsha Hunan China 410005
16 XiangYa Hospital Central South University Changsha Hunan China 410008
17 Zhongda Hospital Southeast University Nanjing Jiangsu China 210009
18 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330209
19 Shanghai Chest Hospital Shanghai Shanghai China 200030
20 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433
21 Xi'an chest hospital Xi'an Shanxi China 710010
22 First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China 710061
23 Zhejiang Provincial People' s Hospital Huangzhou Zhejiang China 310014
24 The First Hospital of Jiaxing Jiaxing Zhejiang China 314000

Sponsors and Collaborators

  • ShiYue Li

Investigators

  • Study Chair: Shiyue Li, master, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ShiYue Li, Guangzhou Institute of Respiratory Disease, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT04661956
Other Study ID Numbers:
  • 20200914
First Posted:
Dec 10, 2020
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ShiYue Li, Guangzhou Institute of Respiratory Disease, Guangzhou Institute of Respiratory Disease
Transbronchial Cryobiopsy
Diagnostic Yield
Safety
Pulmonary Periphral Nodule
Additional relevant MeSH terms:
Disease

Study Results

No Results Posted as of Oct 15, 2021