Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching

Study Overview
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Brief Summary
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The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by autologous blood patch injection (ABPI).

Detailed Description
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Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this risk is a goal of those who perform these procedures, particularly a reduction in large pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been suggested as an effective mean of sealing the punctured lung thus halting air loss and consequently pneumothorax (Graffy et al. 2017). The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI. In particular, the main objectives are to compare: incidence of immediate pneumothorax incidence of late pneumothorax (2 hrs) incidence of chest tube placement duration of the procedure

Official Title
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The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study

Conditions
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Pneumothorax, Biopsy Wound

Intervention / Treatment
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* Other: Autologous blood patch injection (ABPI)
* Other: CT-guided core needle biopsy (CNB)


Participation Criteria
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Eligibility Criteria
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All patients scheduled for lung biopsy will be asked to join this study. After signing the informed consent the subject will be randomized for ABPI vs CNB approach. Inclusion criteria: 1) patients with pulmonary nodule requiring CT-guided lung biopsy. Exclusion criteria: unfit for lung biopsy (INR >1.5, PLT <50.000, single lung); unavailable venous access.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized two arms single center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-guided core needle biopsy (CNB)<br>18 gauge ct-guided lung biopsy | Other: CT-guided core needle biopsy (CNB)<br>* Standard 18g lung core biopsy<br>|
| Experimental: CNB followed by ABPI.<br>17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection | Other: Autologous blood patch injection (ABPI)<br>* Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Pneumothorax after biopsy | Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray | Immediately after lung puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Pneumothorax after biopsy | Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours | 2-6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, pneumothorax