WithdrawnPhase 2

Gelfoam to Prevent Pneumothorax After Lung Biopsy

Stopped: Will re-open at another time

United States0Started 2018-12-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Difference in incidence of pneumothorax

Timeframe: 2 hours post-procedure

Trial details

NCT IDNCT03669003

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01