Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
NCT Number: NCT06563167
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Biopsy
Interventions: DIAGNOSTIC_TEST: CXR
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 330
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: Chinese University of Hong Kong, Hong Kong, Hong Kong

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.

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.

Primary Outcome Measures: 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, 18 months
Secondary Outcome Measures: 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, 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, 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, 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, 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, 18 months|To evaluate the clinical outcome of patients undergoing image-guided TTLB, To evaluate the clinical outcome of patients undergoing image-guided TTLB, 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, 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, 18 months