Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gelfoam to Prevent Pneumothorax After Lung Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669003
Recruitment Status : Withdrawn (Will re-open at another time)
First Posted : September 13, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Prasoon Mohan, University of Miami

Brief Summary:

Lung cancer is the deadliest of all cancers, and its incidence is on the rise. The importance of accurate and efficient lung biopsy without complications will only increase in importance going forward. Pneumothorax is a common complication of CT-guided lung biopsy. The purpose of this study is to assess the efficacy of using Gelfoam slurry in preventing pneumothorax from lung biopsy in a randomized controlled trial. Gelfoam (Pfizer, New York, NY, USA) is gelatin product approved by the Food and Drug Administration (FDA) for hemostasis during various procedures.

In the study group, the needle track will be laced with Gelfoam slurry following biopsy, and will be compared to standard lung biopsy without any other interventions. Both groups will be followed up with chest x-ray for pneumothorax.


Condition or disease Intervention/treatment Phase
Pneumothorax Iatrogenic Postprocedural Biological: Gelfoam slurry Procedure: CT-guided percutaneous lung biopsy Phase 2

Detailed Description:

CT-guided percutaneous lung biopsy is an invaluable tool used for the diagnosis of lung cancer. Pneumothorax (PTX) is the most frequent complication of CT-guided percutaneous lung biopsy, with a reported incidence of 9 to 40% and a cumulative average incidence of about 20%. Most of these are managed conservatively and about 7 to 21% will require placement of a chest tube. Several techniques have been used in the past to prevent the development of PTX by sealing the needle tract with various materials (autologous blood, saline, hydrogel, collagen plugs), but literature has shown them to be unreliable, clumsy or costly.

The use of Gelfoam slurry for embolizing the needle tract following biopsy has been identified in a retrospective study as a possible intervention to reduce the occurrence of pneumothorax and/or chest tube placement. Gelfoam (Pfizer, New York, NY, USA) is a gelatin sponge made from bovine corium, which can absorb fluids 40 times its weight and can enlarge by 200% in size. This property allows the material to effectively plug the biopsy track by volumetric expansion, which prevents passage of air from the lung into the pleural cavity and creation of a pneumothorax. Gelfoam is cheap, is readily available both as a sponge and powder and can be easily made into a slurry by mixing with saline. The slurry is semisolid in consistency and can be easily injected through the biopsy cannula into the needle track.

In the experimental group, as the biopsy cannula is withdrawn, Gelfoam will be injected carefully, lacing the needle track. In both groups, immediate post-procedure CT scans and subsequent follow up X-rays 1 and 2 hours post-procedure will be used to monitor for pneumothorax.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gelfoam Slurry as an Embolization Agent of the Needle Tract to Prevent Pneumothorax From Percutaneous CT-guided Lung Biopsy: A Randomized Controlled Trial
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gelfoam
Gelfoam slurry will be injected at the end of the biopsy procedure.
Biological: Gelfoam slurry
Approximately 1-2cc of Gelfoam slurry will be used to lace the needle track.

Active Comparator: Standard procedure
Standard procedure of lung biopsy
Procedure: CT-guided percutaneous lung biopsy
Biopsy of a lung nodule under CT guidance.




Primary Outcome Measures :
  1. Difference in incidence of pneumothorax [ Time Frame: 2 hours post-procedure ]
    Comparison of the incidence of pneumothorax in participants of standard lung biopsy vs with Gelfoam slurry


Secondary Outcome Measures :
  1. Difference in the rate of necessity for chest tube placement post lung biopsy [ Time Frame: 2 hours post-procedure ]
    Comparison of the necessity for chest tube placement in participants of standard lung biopsy vs with Gelfoam slurry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

To be included in the study, the patient must:

  1. Be between the ages of 18-80.
  2. Be indicated for CT-guided percutaneous lung biopsy for evaluation of a solitary pulmonary nodule, or other indicated pulmonary lesion(s).
  3. Be cooperative.

To be included in the study, the patient must NOT:

  1. Have known allergy to porcine collagen (basis of Gelfoam).
  2. Have bleeding diatheses defined by the following coagulation indices: International normalized ratio [INR]>1.5 /platelets<50,000/µL.
  3. Have had previous pneumonectomy (unless the lesion is pleurally based and accessible without traversing lung tissue.
  4. Have suspected hyatid cyst (due to risk of anaphylactic reaction).
  5. Have possible pulmonary arteriovenous malformation (AVM), vascular aneurysm, or pulmonary sequestration (intralobar or extralobar).
  6. Have a diagnosis of pulmonary hypertension (especially when considering biopsy of a central lesion).
  7. Require positive pressure ventilation.
  8. Require consent of proxy to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669003


Locations
Layout table for location information
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Prasoon Mohan, MD University of Miami
Layout table for additonal information
Responsible Party: Prasoon Mohan, Assistant Professor of Interventional Radiology, University of Miami
ClinicalTrials.gov Identifier: NCT03669003    
Other Study ID Numbers: 20170830
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prasoon Mohan, University of Miami:
lung biopsy
gelfoam
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Gelatin Sponge, Absorbable
Hemostatics
Coagulants