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

January 11, 2019 updated by: Humanitas Clinical and Research Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CT-guided core needle biopsy (CNB)
18 gauge ct-guided lung biopsy
Other: CT-guided core needle biopsy (CNB)
Standard 18g lung core biopsy
Experimental: CNB followed by ABPI.
17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
Other: Autologous blood patch injection (ABPI)
Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Pneumothorax after biopsy
Time Frame: Immediately after lung puncture
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
Immediately after lung puncture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Pneumothorax after biopsy
Time Frame: 2-6 hours
Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours
2-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Clinical and Research Center

Investigators

  • Principal Investigator: EZIO LANZA, MD, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICH-BloodyBiopsy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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