Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-22 @ 5:31 AM
Study NCT ID:
NCT03804957
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2018-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching
Sponsor:
Humanitas Clinical and Research Center
Organization:
Study Overview
Official Title:
The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BloodyBiopsy
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: