Gelfoam to Prevent Pneumothorax After Lung Biopsy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/20/2018 |
| Start Date: | December 1, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Lia Quezada |
| Email: | Lquezada@med.miami.edu |
| Phone: | 305-243-2210 |
Gelfoam Slurry as an Embolization Agent of the Needle Tract to Prevent Pneumothorax From Percutaneous CT-guided Lung Biopsy: A Randomized Controlled Trial
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.
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.
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.
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.
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.
We found this trial at
2
sites
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Miami, Florida 33136
Principal Investigator: Prasoon Mohan, MD
Phone: 305-243-2210
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Prasoon Mohan, MD
Phone: 305-243-2210
University of Miami A private research university with more than 15,000 students from around the...
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