PneumothoraxBloodyBiopsyNCT03804957
Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching
A study testing Autologous blood patch injection (ABPI) and CT-guided core needle biopsy (CNB) in people with Pneumothorax and Biopsy Wound, run by Humanitas Clinical and Research Center at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumothorax, Biopsy Wound
- What is being tested?
- Autologous blood patch injection (ABPI) and CT-guided core needle biopsy (CNB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) patients with pulmonary nodule requiring CT-guided lung biopsy.
Who cannot join
- unfit for lung biopsy (INR >1.5, PLT <50.000, single lung);
- unavailable venous access.
Trial locations and contacts
1 site in 1 country.
FRANCESCA PICCOLI, MD contact
About this study
Official title: The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study
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).
Read the 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
- Conditions
- Pneumothorax, Biopsy Wound
- Being tested
- Autologous blood patch injection (ABPI), CT-guided core needle biopsy (CNB)
- Keywords
- biopsy, pneumothorax
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood patch injection (ABPI)Other
Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
CT-guided core needle biopsy (CNB)Other
Standard 18g lung core biopsy
| Study group | Role | What they receive |
|---|---|---|
| CT-guided core needle biopsy (CNB) | Active comparator | 18 gauge ct-guided lung biopsy Receives: Other: CT-guided core needle biopsy (CNB) |
| CNB followed by ABPI. | Experimental | 17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection Receives: Other: Autologous blood patch injection (ABPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Pneumothorax after biopsy
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
Measured: Immediately after lung puncture
Secondary outcomes (1)
Late Pneumothorax after biopsy
Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours
Measured: 2-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized two arms single center
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EZIO LANZA, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804957
- Sponsor's protocol ID
- ICH-BloodyBiopsy
- Acronym
- BloodyBiopsy
- Status last verified
- Jan 2019
- First submitted
- 24 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30480487Graffy 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.
PubMed 28185770
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT03804957
- Acronym / sponsor ID
- BloodyBiopsy / ICH-BloodyBiopsy
- Conditions
- Pneumothorax, Biopsy Wound
- Keywords
- biopsy, pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized two arms single center
| Arm | Type | Receives |
|---|---|---|
| CT-guided core needle biopsy (CNB) | Active comparator | Other: CT-guided core needle biopsy (CNB)18 gauge ct-guided lung biopsy |
| CNB followed by ABPI. | Experimental | Other: Autologous blood patch injection (ABPI)17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) patients with pulmonary nodule requiring CT-guided lung biopsy.
Key exclusion criteria (2 listed)
- unfit for lung biopsy (INR >1.5, PLT <50.000, single lung);
- unavailable venous access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous blood patch injection (ABPI)Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy | Other | CNB followed by ABPI. |
| CT-guided core needle biopsy (CNB)Standard 18g lung core biopsy | Other | CT-guided core needle biopsy (CNB) |
Primary outcome
Early Pneumothorax after biopsy
Time frame: Immediately after lung puncture
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
1 secondary outcome
Late Pneumothorax after biopsy
Time frame: 2-6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Results publication: PubMed 30480487Maybody 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 publication: PubMed 28185770Graffy 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumothorax
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Not yet recruitingObservational study
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Pneumothorax, Intestinal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FRANCESCA PICCOLI, MD contact
EZIO LANZA, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood patch injection (ABPI) and CT-guided core needle biopsy (CNB) in people with Pneumothorax and Biopsy Wound, run by Humanitas Clinical and Research Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EZIO LANZA, MD (0282247383, eziolanza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Pneumothorax after biopsy (time frame: Immediately after lung puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804957, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.