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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-guided core needle biopsy (CNB) | Active Comparator | 18 gauge ct-guided lung biopsy |
|
| CNB followed by ABPI. | Experimental | 17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous blood patch injection (ABPI) | Other | Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Late Pneumothorax after biopsy | Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours | 2-6 hours |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EZIO LANZA, MD | Contact | 0282247383 | eziolanza@gmail.com | |
| FRANCESCA PICCOLI, MD | Contact | francesca.piccoli3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| EZIO LANZA, MD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Lombardy | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30480487 | Result | Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27. | |
| 28185770 |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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Randomized two arms single center
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| CT-guided core needle biopsy (CNB) | Other | Standard 18g lung core biopsy |
|
| Result |
| Graffy P, Loomis SB, Pickhardt PJ, Lubner MG, Kitchin DR, Lee FT Jr, Hinshaw JL. Pulmonary Intraparenchymal Blood Patching Decreases the Rate of Pneumothorax-Related Complications following Percutaneous CT-Guided Needle Biopsy. J Vasc Interv Radiol. 2017 Apr;28(4):608-613.e1. doi: 10.1016/j.jvir.2016.12.1217. Epub 2017 Feb 6. |