Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy

ConditionLung Biopsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CXR

    Diagnostic 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.

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: CXR receipients1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
18 months

Secondary outcomes

1

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

Time frame
18 months
2

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

Time frame
18 months
3

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

Time frame
18 months
4

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

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.