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

Not Applicable

• Conditions: Biopsy Wound; Pneumothorax
• Interventions: Other: Autologous blood patch injection (ABPI); Other: CT-guided core needle biopsy (CNB)

• Registration Number: NCT03804957
• Lead Sponsor: Humanitas Clinical and Research Center

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

Study Timeline

• Study First Submitted: 2018-12-24
• Status Verified: 2019-01
• Study Start: 2019-01
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CNB followed by ABPI.	Autologous blood patch injection (ABPI)	17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
CT-guided core needle biopsy (CNB)	CT-guided core needle biopsy (CNB)	18 gauge ct-guided lung biopsy

Primary Outcome Measures

Name	Time	Method
Early Pneumothorax after biopsy	Immediately after lung puncture	Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray

Secondary Outcome Measures

Name	Time	Method
Late Pneumothorax after biopsy	2-6 hours	Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Lombardia, Italy