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出境医 / 临床实验 / The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease

The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Study Description
Brief Summary:
To compariing the uniportal and tubeless video assisted thoracic surgery and trnsbronchial lung cryobiopsy within the multidisciplinary discussion context in the diagnosis of interstitial lung disease，and assess the safety and cost-effectiveness. This is a prospective control trial.

Condition or disease Intervention/treatment Phase
Surgical Lung Biopsy Transbronchial Lung Cryobiopsy Interstitial Lung Disease Diagnostic Test: lung biopsy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy Within the Multidisciplinary Discussion Context in the Diagnosis of Interstitial Lung Disease
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: uniportal and tubeless video assisted thoracic surgery
lung biospy by the uniportal and tubeless video assisted thoracic surgery
 Diagnostic Test: lung biopsy
transbronchial lung cryobiopsy
Experimental: transbronchial lung cryobiopsy
transbronchial lung cryobiopsy
 Diagnostic Test: lung biopsy
transbronchial lung cryobiopsy
Outcome Measures
Primary Outcome Measures :
  1. Diagnotic yield [ Time Frame: two weeks ]
    Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 yrs ≤ age<75yrs
  2. Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)
  3. Further pathological data was still required after multidisciplinary discussion.

Exclusion Criteria:

  1. Severe pulmonary dysfunction: forced vital capacity (FVC) ≤65% or carbon-monoxide diffusion coefficient (DLco) ≤45% of predicted value
  2. Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography
  3. Abnormal coagulation parameters or thrombocytopenia (<50*109/L)
  4. Severe comorbidities leading to inoperable condition
  5. Patients cannot give consent or refuse biopsy
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xiaobo Chen, Doctor +8613751721744 xiaobo-win@163.com

Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019) 		Diagnotic yield [ Time Frame: two weeks ]
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
Official Title  ICMJE The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy Within the Multidisciplinary Discussion Context in the Diagnosis of Interstitial Lung Disease
Brief Summary To compariing the uniportal and tubeless video assisted thoracic surgery and trnsbronchial lung cryobiopsy within the multidisciplinary discussion context in the diagnosis of interstitial lung disease，and assess the safety and cost-effectiveness. This is a prospective control trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Surgical Lung Biopsy
  • Transbronchial Lung Cryobiopsy
  • Interstitial Lung Disease
Intervention  ICMJE Diagnostic Test: lung biopsy
transbronchial lung cryobiopsy
Study Arms  ICMJE
  • Experimental: uniportal and tubeless video assisted thoracic surgery
    lung biospy by the uniportal and tubeless video assisted thoracic surgery
    Intervention: Diagnostic Test: lung biopsy
  • Experimental: transbronchial lung cryobiopsy
    transbronchial lung cryobiopsy
    Intervention: Diagnostic Test: lung biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 yrs ≤ age<75yrs
  2. Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)
  3. Further pathological data was still required after multidisciplinary discussion.

Exclusion Criteria:

  1. Severe pulmonary dysfunction: forced vital capacity (FVC) ≤65% or carbon-monoxide diffusion coefficient (DLco) ≤45% of predicted value
  2. Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography
  3. Abnormal coagulation parameters or thrombocytopenia (<50*109/L)
  4. Severe comorbidities leading to inoperable condition
  5. Patients cannot give consent or refuse biopsy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958162
Other Study ID Numbers  ICMJE TS20181008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ShiYue Li, Guangzhou Institute of Respiratory Disease
Study Sponsor  ICMJE Guangzhou Institute of Respiratory Disease
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guangzhou Institute of Respiratory Disease
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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