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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03804957

Acronym

BloodyBiopsy

Enrollment

200

Registered

2019-01-15

Start date

2019-01-31

Completion date

2020-04-30

Last updated

2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biopsy Wound, Pneumothorax

Keywords

biopsy, pneumothorax

Brief summary

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

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: 1. incidence of immediate pneumothorax 2. incidence of late pneumothorax (2 hrs) 3. incidence of chest tube placement 4. duration of the procedure

Interventions

OTHERAutologous blood patch injection (ABPI)

Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy

OTHERCT-guided core needle biopsy (CNB)

Standard 18g lung core biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Randomized two arms single center

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

1. unfit for lung biopsy (INR \>1.5, PLT \<50.000, single lung); 2. unavailable venous access.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactEZIO LANZA, MD

eziolanza@gmail.com0282247383

Backup ContactFRANCESCA PICCOLI, MD

francesca.piccoli3@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026