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

Pneumothorax Clinical Trial

— BloodyBiopsy  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804957
• Other study ID #: ICH-BloodyBiopsy
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: April 2020

Study information

• Verified date: January 2019
• Source: Humanitas Clinical and Research Center
• Contact: EZIO LANZA, MD
• Phone: 0282247383
• Email: eziolanza[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biopsy Wound
• Pneumothorax

Intervention

Other:
• Autologous blood patch injection (ABPI)
Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
• CT-guided core needle biopsy (CNB)
Standard 18g lung core biopsy

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Pneumothorax after biopsy	Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray	Immediately after lung puncture
Secondary	Late Pneumothorax after biopsy	Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours	2-6 hours