Lung BiopsyNCT06563167
Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
An observational study of Lung Biopsy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objective: The goal of this study is to evaluate the sensitivity and specificity of the presence of pneumothorax on a 4-hour CXR after image-guided transthoracic lung biopsy (TTLB) for diagnosing subsequent clinically significant pneumothorax. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Biopsy
- What is being tested?
- CXR
- How many people
- 330 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will require image-guided TTLB
Who may be able to join
- Patients whose image-guided TTLB, including ultrasound or CT-guided, is arranged for diagnostic purposes
- Patients who are able to sign written informed consent to participate in the study
Who cannot join
- Patients with resolution of lung lesion prior to the scheduled image-guided TTLB
- Patients have active exacerbation of underlying diseases causing unstable respiratory conditions (e.g. exacerbation of COPD, pneumonia) which would lower the threshold for invasive interventions for iatrogenic pneumothorax
- Patients with psychiatric disease or cognitive impairment that may limit their ability to understand or give consent to the study
- Patients who decline to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
Objective: The goal of this study is to evaluate the sensitivity and specificity of the presence of pneumothorax on a 4-hour CXR after image-guided transthoracic lung biopsy (TTLB) for diagnosing subsequent clinically significant pneumothorax.
Hypothesis to be tested: The investigators hypothesize that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours.
Read more
Design and subjects: This is a prospective, single-centre, diagnostic accuracy study conducted at a tertiary referral centre in Hong Kong. Patients will be recruited if an image-guided TTLB is arranged.
Study instruments: CXRs will be performed for patients at different time points. The presence and size of pneumothorax (if any) will be recorded.
Outcome: The diagnostic capacity of a 4-hour CXR after image-guided TTLB will be provide evidence regarding the safety and patient selection for same-day discharge.
Read the detailed description
Image-guided transthoracic lung biopsy (TTLB), by computed tomography (CT) or ultrasound guidance, is an important diagnostic modality for various pulmonary diseases. One of the most common and clinically important complications of TTLB is iatrogenic pneumothorax. The estimated incidence of iatrogenic pneumothorax following TTLB ranges between 12 and 45%, and 2 to 15% of these patients required chest drain insertion.
The majority of post-TTLB iatrogenic pneumothorax occurs immediately after the procedure, but delayed pneumothorax, which happened hours after the biopsy, is a recognized complication. The incidence rate of delayed pneumothorax ranges between 0.4 and 8.6%, and mostly could be detected at or within 4 hours after biopsy. Among these delayed pneumothorax, up to 60% were clinically significant and required chest drain insertion.
There is no high-quality evidence informing physicians of the best timing of CXR in detecting delayed pneumothorax. An ideal timing for this CXR should be late enough to capture the most delayed clinically significant pneumothorax yet promptly detect deterioration due to pneumothorax. The British Thoracic Society guideline recommends an erect CXR 1 hour after the biopsy, which is sufficient to detect the majority of post-biopsy pneumothorax. The guideline also mentions that patients should be warned of delayed pneumothorax but does not mandate the need for subsequent CXR. Overnight observation with a CXR the next day, i.e. 16 to 20 hours after biopsy, is a common local practice to detect the occurrence of delayed pneumothorax. This practice, although safe, has not been examined extensively and involves a longer hospital stay for all patients receiving TTLB. TTLB as a day procedure has been described instead. A series of CXRs were used to ensure adequate detection of enlarging iatrogenic pneumothorax, but it was labour-intensive.
Our group conducted an internal audit covering 3 months of hospital data in Prince of Wales Hospital, which includes 109 patients who underwent image-guided TTLB between Nov 2023 and Jan 2024. The incidences of pneumothorax and clinically significant pneumothorax requiring chest drain insertion were 23 (21.1%) and 7 (6.4%), respectively. Among those patients who had chest drain insertion, 4 had drains inserted within 3 hours after biopsy. The remaining 3 patients had chest drains inserted at 16 to 19 hours after biopsy. Their initial CXR at 1 hour showed no pneumothorax, but did not receive interim CXR in between. A separate group of 11 patients with CXR between 3 to 6 hours and no clinically significant pneumothorax were safely discharged the next day. These preliminary data suggest that an interim CXR at 4 hours may allow timely detection of clinically significant pneumothorax for early intervention, and an absence of pneumothorax at 4 hours can rule out the possibility of delayed pneumothorax at a later time point. This may facilitate early discharge in at least 80% of patients.
This prospective study aims to evaluate the diagnostic capacity of a 4-hour CXR after image-guided TTLB in predicting the clinically significant pneumothorax at 16 to 20 hours after biopsy. The investigators hypothesized that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours. As the best way of measuring the size of iatrogenic pneumothorax has not been defined, several pragmatic methods with arbitrary cutoff values will be assessed in the study, including a binary outcome of pneumothorax (present or absent), apex-to-cupula distance (≤ 2 cm or > 2 cm), width of pneumothorax at the hilar level (≤ 1 cm or > 1 cm), Light's method (≤ 10% or > 10%) [11] and Collins method (≤ 10% or > 10%) [12]. The data collected from this study will provide evidence regarding the safety and patient selection for same-day discharge in patients undergoing image-guided TTLB.
- Conditions
- Lung Biopsy
- Being tested
- CXR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXRDiagnostic test
CXRs will be performed at 3 different time points - (i) within 1 hour after TTLB, (ii) at 4 hours (± 1 hour) after TTLB and (iii) at 18 hours (± 2 hours) after TTLB.
| Study group | Role | What they receive |
|---|---|---|
| CXR receipients | Patients who will receive CXR after lung biopsy Receives: Diagnostic Test: CXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing subsequent clinically significant pneumothorax
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing subsequent clinically significant pneumothorax
Measured: 18 months
Secondary outcomes (8)
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint of subsequent clinically significant pneumothorax, need for in-hospital observation of more than 1 day and unplanned readmission for pneumothorax within 2 weeks
Measured: 18 months
The sensitivity and specificity of the pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
The sensitivity and specificity of the pneumothorax with an apex-to-cupola distance of greater than 2cm, pneumothorax with a size of greater than 1cm at the hilar level, pneumothorax with a size of greater than 10% by Light's method and pneumothorax with a size of greater than 10% by Collins method on T1 CXR after image-guided TTLB for diagnosing a composite endpoint of subsequent clinically significant pneumothorax, need for in-hospital observation of more than 1 day and unplanned readmission for pneumothorax within 2 weeks
Measured: 18 months
The difference in the area under the curve (AUC) between the receiver operating characteristic (ROC) curves of pneumothorax size measured by different methods on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
The difference in the area under the curve (AUC) between the receiver operating characteristic (ROC) curves of pneumothorax size measured by different methods (presence or absence of pneumothorax, apex-to-cupola distance, hilar level, Light's method and Collins method) on T1 CXR after image-guided TTLB for diagnosing a composite endpoint of subsequent clinically significant pneumothorax, need for in-hospital observation more than 1 day and unplanned readmission for pneumothorax within 2 weeks
Measured: 18 months
To evaluate the incidence rate of clinically significant pneumothorax between T0 and T1 after image-guided TTLB
To evaluate the incidence rate of clinically significant pneumothorax between T0 and T1 after image-guided TTLB
Measured: 18 months
To evaluate the incidence rate of clinically significant pneumothorax between T1 and T2 after image-guided TTLB
To evaluate the incidence rate of clinically significant pneumothorax between T1 and T2 after image-guided TTLB
Measured: 18 months
To evaluate the clinical outcome of patients undergoing image-guided TTLB
To evaluate the clinical outcome of patients undergoing image-guided TTLB
Measured: 18 months
To identify the risk factors related to early and delayed iatrogenic pneumothorax after TTLB
To identify the risk factors related to early (between T0 and T1) and delayed (beyond T1) iatrogenic pneumothorax after TTLB
Measured: 18 months
To compare the rate of complete radiographic resolution of pneumothorax for patients with iatrogenic pneumothorax who received conservative and invasive treatment
To compare the rate of complete radiographic resolution of pneumothorax at 3 weeks (± 1 week) for patients with iatrogenic pneumothorax who received conservative and invasive treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung BiopsyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Pang Chan, Chinese University of Hong Kong
- Investigators
- David SC Hui, MD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563167
- Sponsor's protocol ID
- PWH_TTLB
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
- ClinicalTrials.gov ID
- NCT06563167
- Acronym / sponsor ID
- PWH_TTLB
- Conditions
- Lung Biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2024 (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.
Objective: The goal of this study is to evaluate the sensitivity and specificity of the presence of pneumothorax on a 4-hour CXR after image-guided transthoracic lung biopsy (TTLB) for diagnosing subsequent clinically significant pneumothorax.
Hypothesis to be tested: The investigators hypothesize that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours.
Design and subjects: This is a prospective, single-centre, diagnostic accuracy study conducted at a tertiary referral centre in Hong Kong. Patients will be recruited if an image-guided TTLB is arranged.
Study instruments: CXRs will be performed for patients at different time points. The presence and size of pneumothorax (if any) will be recorded.
Outcome: The diagnostic capacity of a 4-hour CXR after image-guided TTLB will be provide evidence regarding the safety and patient selection for same-day discharge.
Detailed description
Image-guided transthoracic lung biopsy (TTLB), by computed tomography (CT) or ultrasound guidance, is an important diagnostic modality for various pulmonary diseases. One of the most common and clinically important complications of TTLB is iatrogenic pneumothorax. The estimated incidence of iatrogenic pneumothorax following TTLB ranges between 12 and 45%, and 2 to 15% of these patients required chest drain insertion.
The majority of post-TTLB iatrogenic pneumothorax occurs immediately after the procedure, but delayed pneumothorax, which happened hours after the biopsy, is a recognized complication. The incidence rate of delayed pneumothorax ranges between 0.4 and 8.6%, and mostly could be detected at or within 4 hours after biopsy. Among these delayed pneumothorax, up to 60% were clinically significant and required chest drain insertion.
There is no high-quality evidence informing physicians of the best timing of CXR in detecting delayed pneumothorax. An ideal timing for this CXR should be late enough to capture the most delayed clinically significant pneumothorax yet promptly detect deterioration due to pneumothorax. The British Thoracic Society guideline recommends an erect CXR 1 hour after the biopsy, which is sufficient to detect the majority of post-biopsy pneumothorax. The guideline also mentions that patients should be warned of delayed pneumothorax but does not mandate the need for subsequent CXR. Overnight observation with a CXR the next day, i.e. 16 to 20 hours after biopsy, is a common local practice to detect the occurrence of delayed pneumothorax. This practice, although safe, has not been examined extensively and involves a longer hospital stay for all patients receiving TTLB. TTLB as a day procedure has been described instead. A series of CXRs were used to ensure adequate detection of enlarging iatrogenic pneumothorax, but it was labour-intensive.
Our group conducted an internal audit covering 3 months of hospital data in Prince of Wales Hospital, which includes 109 patients who underwent image-guided TTLB between Nov 2023 and Jan 2024. The incidences of pneumothorax and clinically significant pneumothorax requiring chest drain insertion were 23 (21.1%) and 7 (6.4%), respectively. Among those patients who had chest drain insertion, 4 had drains inserted within 3 hours after biopsy. The remaining 3 patients had chest drains inserted at 16 to 19 hours after biopsy. Their initial CXR at 1 hour showed no pneumothorax, but did not receive interim CXR in between. A separate group of 11 patients with CXR between 3 to 6 hours and no clinically significant pneumothorax were safely discharged the next day. These preliminary data suggest that an interim CXR at 4 hours may allow timely detection of clinically significant pneumothorax for early intervention, and an absence of pneumothorax at 4 hours can rule out the possibility of delayed pneumothorax at a later time point. This may facilitate early discharge in at least 80% of patients.
This prospective study aims to evaluate the diagnostic capacity of a 4-hour CXR after image-guided TTLB in predicting the clinically significant pneumothorax at 16 to 20 hours after biopsy. The investigators hypothesized that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours. As the best way of measuring the size of iatrogenic pneumothorax has not been defined, several pragmatic methods with arbitrary cutoff values will be assessed in the study, including a binary outcome of pneumothorax (present or absent), apex-to-cupula distance (≤ 2 cm or > 2 cm), width of pneumothorax at the hilar level (≤ 1 cm or > 1 cm), Light's method (≤ 10% or > 10%) [11] and Collins method (≤ 10% or > 10%) [12]. The data collected from this study will provide evidence regarding the safety and patient selection for same-day discharge in patients undergoing image-guided TTLB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXR receipients | – | Diagnostic Test: CXRPatients who will receive CXR after lung biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will require image-guided TTLB
Key inclusion criteria (2 listed)
- Patients whose image-guided TTLB, including ultrasound or CT-guided, is arranged for diagnostic purposes
- Patients who are able to sign written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Patients with resolution of lung lesion prior to the scheduled image-guided TTLB
- Patients have active exacerbation of underlying diseases causing unstable respiratory conditions (e.g. exacerbation of COPD, pneumonia) which would lower the threshold for invasive interventions for iatrogenic pneumothorax
- Patients with psychiatric disease or cognitive impairment that may limit their ability to understand or give consent to the study
- Patients who decline to join the study
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 |
|---|---|---|
| CXRCXRs will be performed at 3 different time points - (i) within 1 hour after TTLB, (ii) at 4 hours (± 1 hour) after TTLB and (iii) at 18 hours (± 2 hours) after TTLB. | Diagnostic test | CXR receipients |
Primary outcome
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing subsequent clinically significant pneumothorax
Time frame: 18 months
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing subsequent clinically significant pneumothorax
8 secondary outcomes
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
Time frame: 18 months
The sensitivity and specificity of the pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
Time frame: 18 months
The difference in the area under the curve (AUC) between the receiver operating characteristic (ROC) curves of pneumothorax size measured by different methods on T1 CXR after image-guided TTLB for diagnosing a composite endpoint
Time frame: 18 months
To evaluate the incidence rate of clinically significant pneumothorax between T0 and T1 after image-guided TTLB
Time frame: 18 months
To evaluate the incidence rate of clinically significant pneumothorax between T1 and T2 after image-guided TTLB
Time frame: 18 months
To evaluate the clinical outcome of patients undergoing image-guided TTLB
Time frame: 18 months
To identify the risk factors related to early and delayed iatrogenic pneumothorax after TTLB
Time frame: 18 months
To compare the rate of complete radiographic resolution of pneumothorax for patients with iatrogenic pneumothorax who received conservative and invasive treatment
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
David SC Hui, MD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Biopsy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the presence of pneumothorax on T1 CXR after image-guided TTLB for diagnosing subsequent clinically significant pneumothorax (time frame: 18 months). 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 3 Sep 2026.