Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching
BloodyBiopsy
The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJanuary 15, 2019
January 1, 2019
11 months
December 24, 2018
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early Pneumothorax after biopsy
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
Immediately after lung puncture
Secondary Outcomes (1)
Late Pneumothorax after biopsy
2-6 hours
Study Arms (2)
CT-guided core needle biopsy (CNB)
ACTIVE COMPARATOR18 gauge ct-guided lung biopsy
CNB followed by ABPI.
EXPERIMENTAL17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
Interventions
Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
Standard 18g lung core biopsy
Eligibility Criteria
You may qualify if:
- \) patients with pulmonary nodule requiring CT-guided lung biopsy.
You may not qualify if:
- unfit for lung biopsy (INR \>1.5, PLT \<50.000, single lung);
- unavailable venous access.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanitas Research Hospital
Rozzano, Lombardy, 20089, Italy
Related Publications (2)
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.
PMID: 30480487RESULTGraffy 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.
PMID: 28185770RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EZIO LANZA, MD
Humanitas Research Hospital IRCCS, Rozzano-Milan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2018
First Posted
January 15, 2019
Study Start
January 1, 2019
Primary Completion
December 1, 2019
Study Completion
April 1, 2020
Last Updated
January 15, 2019
Record last verified: 2019-01