Gelfoam to Prevent Pneumothorax After Lung Biopsy

NCT03669003 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 20170830
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumothorax Iatrogenic Postprocedural

Keywords

lung biopsy; gelfoam

Outcome Measures

Primary Outcomes (1)

• Difference in incidence of pneumothorax

  Comparison of the incidence of pneumothorax in participants of standard lung biopsy vs with Gelfoam slurry

  2 hours post-procedure

Secondary Outcomes (1)

• Difference in the rate of necessity for chest tube placement post lung biopsy

  2 hours post-procedure

Study Arms (2)

Gelfoam

EXPERIMENTAL

Gelfoam slurry will be injected at the end of the biopsy procedure.

Biological: Gelfoam slurry

Standard procedure

ACTIVE COMPARATOR

Standard procedure of lung biopsy

Procedure: CT-guided percutaneous lung biopsy

Interventions

Gelfoam slurry BIOLOGICAL

Approximately 1-2cc of Gelfoam slurry will be used to lace the needle track.

Gelfoam

CT-guided percutaneous lung biopsy PROCEDURE

Biopsy of a lung nodule under CT guidance.

Standard procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Prasoon Mohan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Interventional Radiology

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

US (2)