Clinical trial NCT03669003: Gelfoam to Prevent Pneumothorax After Lung Biopsy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pneumothorax Iatrogenic Postprocedural
Keywords: lung biopsy
gelfoam
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Difference in incidence of pneumothorax
timeFrame: 2 hours post-procedure
Secondary outcomes:
measure: Difference in the rate of necessity for chest tube placement post lung biopsy
timeFrame: 2 hours post-procedure
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Prasoon Mohan, MD
role: PRINCIPAL_INVESTIGATOR
References: