The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 21, 2019
May 1, 2019
1 year
May 20, 2019
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnotic yield
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
two weeks
Study Arms (2)
uniportal and tubeless video assisted thoracic surgery
EXPERIMENTALlung biospy by the uniportal and tubeless video assisted thoracic surgery
transbronchial lung cryobiopsy
EXPERIMENTALtransbronchial lung cryobiopsy
Interventions
transbronchial lung cryobiopsy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Respiratory department
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 21, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
May 21, 2019
Record last verified: 2019-05