Surgical Lung BiopsyNCT03958162
The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease
A study testing lung biopsy in people with Surgical Lung Biopsy and Transbronchial Lung Cryobiopsy, run by Guangzhou Institute of Respiratory Disease.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Lung Biopsy, Transbronchial Lung Cryobiopsy, Interstitial Lung Disease
- What is being tested?
- lung biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Being tested
- lung biopsy
- Keywords
- surgical lung biopsy, transbronchial lung cryobiopsy, interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung biopsyDiagnostic test
transbronchial lung cryobiopsy
| Study group | Role | What they receive |
|---|---|---|
| uniportal and tubeless video assisted thoracic surgery | Experimental | lung biospy by the uniportal and tubeless video assisted thoracic surgery Receives: Diagnostic Test: lung biopsy |
| transbronchial lung cryobiopsy | Experimental | transbronchial lung cryobiopsy Receives: Diagnostic Test: lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnotic yield
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Lung BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958162
- Sponsor's protocol ID
- TS20181008
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03958162
- Acronym / sponsor ID
- TS20181008
- Keywords
- surgical lung biopsy, transbronchial lung cryobiopsy, interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uniportal and tubeless video assisted thoracic surgery | Experimental | Diagnostic Test: lung biopsylung biospy by the uniportal and tubeless video assisted thoracic surgery |
| transbronchial lung cryobiopsy | Experimental | Diagnostic Test: lung biopsytransbronchial lung cryobiopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung biopsytransbronchial lung cryobiopsy | Diagnostic test | transbronchial lung cryobiopsy, uniportal and tubeless video assisted thoracic surgery |
Primary outcome
Diagnotic yield
Time frame: two weeks
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Lung Biopsy
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
Enrolling by invitationPhase 3
Protest Trial: TXA vs Saline
Lung Transplant, Complications Surgical
RecruitingObservational study
Real-Time Imaging to Improve Lung Cancer Diagnosis : Comparing Confocal Laser Endomicroscopy (CLE) With Standard Biopsy for Quicker and Safer Detection of Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer
RecruitingPhase 2
Using ctDNA to Determine Therapies for Lung Cancer
Non Small Cell Lung Cancer, Complete Surgical Resection
Not yet recruiting
The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
Pulmonary Nodules, Lung Cancer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing lung biopsy in people with Surgical Lung Biopsy and Transbronchial Lung Cryobiopsy, run by Guangzhou Institute of Respiratory Disease.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Chen, Doctor (+8613751721744, xiaobo-win@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnotic yield (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.