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

Primary Purpose

Pneumothorax, Biopsy Wound

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Autologous blood patch injection (ABPI)
CT-guided core needle biopsy (CNB)
Sponsored by
Humanitas Clinical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumothorax focused on measuring biopsy, pneumothorax

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Humanitas Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CT-guided core needle biopsy (CNB)

CNB followed by ABPI.

Arm Description

18 gauge ct-guided lung biopsy

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

Outcomes

Primary Outcome Measures

Early Pneumothorax after biopsy
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray

Secondary Outcome Measures

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

Full Information

First Posted
December 24, 2018
Last Updated
January 11, 2019
Sponsor
Humanitas Clinical and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03804957
Brief Title
Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanitas Clinical and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Biopsy Wound
Keywords
biopsy, pneumothorax

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized two arms single center
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-guided core needle biopsy (CNB)
Arm Type
Active Comparator
Arm Description
18 gauge ct-guided lung biopsy
Arm Title
CNB followed by ABPI.
Arm Type
Experimental
Arm Description
17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
Intervention Type
Other
Intervention Name(s)
Autologous blood patch injection (ABPI)
Intervention Description
Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
Intervention Type
Other
Intervention Name(s)
CT-guided core needle biopsy (CNB)
Intervention Description
Standard 18g lung core biopsy
Primary Outcome Measure Information:
Title
Early Pneumothorax after biopsy
Description
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
Time Frame
Immediately after lung puncture
Secondary Outcome Measure Information:
Title
Late Pneumothorax after biopsy
Description
Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours
Time Frame
2-6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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: unfit for lung biopsy (INR >1.5, PLT <50.000, single lung); unavailable venous access.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EZIO LANZA, MD
Phone
0282247383
Email
eziolanza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FRANCESCA PICCOLI, MD
Email
francesca.piccoli3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EZIO LANZA, MD
Organizational Affiliation
Humanitas Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30480487
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 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.
Results Reference
result
PubMed Identifier
28185770
Citation
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.
Results Reference
result

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

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