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

October 14, 2021 updated by: ShiYue Li

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Contact:
      • Hefei, Anhui, China, 230003
        • Not yet recruiting
        • Anhui Chest Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361021
        • Recruiting
        • Xiamen Second Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
        • Contact:
      • Lanzhou, Gansu, China, 730099
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:
          • Luo Shaohua
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Southern Medical University Nanfang Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518106
        • Not yet recruiting
        • Shenzhen Guangming New District People's Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430014
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, Hubei, China, 430015
        • Not yet recruiting
        • Hubei Provincial Hospital of Integrated Chinese & Western Medicine
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • People's Hospital of Hunan Province
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Zhongda Hospital Southeast University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Contact:
          • Chen Junxiang
      • Shanghai, Shanghai, China, 200433
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Contact:
          • Yang Li
    • Shanxi
      • Xi'an, Shanxi, China, 710010
        • Not yet recruiting
        • Xi'an Chest Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Contact:
    • Zhejiang
      • Huangzhou, Zhejiang, China, 310014
      • Jiaxing, Zhejiang, China, 314000
        • Not yet recruiting
        • The First Hospital of Jiaxing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnotic yield
Time Frame: six months
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: one week
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShiYue Li

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Anticipated)

June 15, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200914

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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