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

NCT06563167 | Recruiting

• 1 other identifier: PWH_TTLB
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Biopsy

Outcome Measures

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

  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

  18 months

• The sensitivity and specificity of the pneumothorax on T1 CXR after image-guided TTLB for diagnosing a composite endpoint

  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

  18 months

• 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

  18 months

Study Arms (1)

CXR receipients

Patients who will receive CXR after lung biopsy

Diagnostic Test: CXR

Interventions

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.

CXR receipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will require image-guided TTLB

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

• David SC Hui, MD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

+852 3505 2211; chankapang@cuhk.edu.hk

Ka Pang Chan, MBChB

CONTACT

+852 3505 3396; chankapang@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)