Gelfoam to Prevent Pneumothorax After Lung Biopsy
|ClinicalTrials.gov Identifier: NCT03669003|
Recruitment Status : Withdrawn (Will re-open at another time)
First Posted : September 13, 2018
Last Update Posted : April 30, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669003
|United States, Florida|
|Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Prasoon Mohan, MD||University of Miami|