Back to resultsThe Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
Primary Purpose
Surgical Lung Biopsy, Transbronchial Lung Cryobiopsy, Interstitial Lung Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lung biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Surgical Lung Biopsy focused on measuring surgical lung biopsy, transbronchial lung cryobiopsy, interstitial lung disease
Eligibility Criteria
Inclusion Criteria:
- 18 yrs ≤ age<75yrs
- Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)
- Further pathological data was still required after multidisciplinary discussion.
Exclusion Criteria:
- Severe pulmonary dysfunction: forced vital capacity (FVC) ≤65% or carbon-monoxide diffusion coefficient (DLco) ≤45% of predicted value
- Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography
- Abnormal coagulation parameters or thrombocytopenia (<50*109/L)
- Severe comorbidities leading to inoperable condition
- Patients cannot give consent or refuse biopsy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
uniportal and tubeless video assisted thoracic surgery
transbronchial lung cryobiopsy
Arm Description
lung biospy by the uniportal and tubeless video assisted thoracic surgery
transbronchial lung cryobiopsy
Outcomes
Primary Outcome Measures
Diagnotic yield
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
Secondary Outcome Measures
Full Information
NCT ID
NCT03958162
First Posted
May 20, 2019
Last Updated
May 20, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT03958162
Brief Title
The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Lung Biopsy, Transbronchial Lung Cryobiopsy, Interstitial Lung Disease
Keywords
surgical lung biopsy, transbronchial lung cryobiopsy, interstitial lung disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
uniportal and tubeless video assisted thoracic surgery
Arm Type
Experimental
Arm Description
lung biospy by the uniportal and tubeless video assisted thoracic surgery
Arm Title
transbronchial lung cryobiopsy
Arm Type
Experimental
Arm Description
transbronchial lung cryobiopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
lung biopsy
Intervention Description
transbronchial lung cryobiopsy
Primary Outcome Measure Information:
Title
Diagnotic yield
Description
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 yrs ≤ age<75yrs
Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)
Further pathological data was still required after multidisciplinary discussion.
Exclusion Criteria:
Severe pulmonary dysfunction: forced vital capacity (FVC) ≤65% or carbon-monoxide diffusion coefficient (DLco) ≤45% of predicted value
Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography
Abnormal coagulation parameters or thrombocytopenia (<50*109/L)
Severe comorbidities leading to inoperable condition
Patients cannot give consent or refuse biopsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Chen, Doctor
Phone
+8613751721744
Email
xiaobo-win@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
We'll reach out to this number within 24 hrs