Gelfoam to Prevent Pneumothorax After Lung Biopsy

Phase 2

Withdrawn

• Conditions: Pneumothorax Iatrogenic Postprocedural
• Interventions: Biological: Gelfoam slurry; Procedure: CT-guided percutaneous lung biopsy

• Registration Number: NCT03669003
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelfoam	Gelfoam slurry	Gelfoam slurry will be injected at the end of the biopsy procedure.
Standard procedure	CT-guided percutaneous lung biopsy	Standard procedure of lung biopsy

Primary Outcome Measures

Name	Time	Method
Difference in incidence of pneumothorax	2 hours post-procedure	Comparison of the incidence of pneumothorax in participants of standard lung biopsy vs with Gelfoam slurry

Secondary Outcome Measures

Name	Time	Method
Difference in the rate of necessity for chest tube placement post lung biopsy	2 hours post-procedure	Comparison of the necessity for chest tube placement in participants of standard lung biopsy vs with Gelfoam slurry

Trial Locations

Locations (2)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States