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

Humanitas Clinical and Research Center

Status: Unknown

Conditions: Pneumothorax; Biopsy Wound

Treatments: Other: Autologous blood patch injection (ABPI); Other: CT-guided core needle biopsy (CNB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03804957

ICH-BloodyBiopsy

Details and patient eligibility

About

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).

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

CT-guided core needle biopsy (CNB)

Active Comparator group

Description:

18 gauge ct-guided lung biopsy

Treatment:

Other: CT-guided core needle biopsy (CNB)

CNB followed by ABPI.

Experimental group

Description:

17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection

Treatment:

Other: Autologous blood patch injection (ABPI)