About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients who will require image-guided TTLB
Trial design
Cohort
Prospective
Treatments tested in this trial
CXR
Diagnostic testCXRs 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
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
Sponsors and contacts
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