Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

Lung Biopsy Clinical Trial

Official title:

Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224924
• Other study ID #: 14-141
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2014
• Est. completion date: January 11, 2023

Study information

• Verified date: January 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.

Description:

This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Referred for CT guided biopsy of lung lesion

• Target lesion of any size

• Target lesion located 1.5 cm or more away from visceral pleura based on the needle path

• Skin thickness =7 cm (from skin to pleura)

• Needle path without transgression of pleural fissure bleb, or bulla is possible

• Coaxial biopsy technique using Angiotech 19-Gauge introducer needle

• Needle length =15

Exclusion Criteria:

• Passage through non-aerated lung or tissue

• More than 1 biopsy on the same side requiring more than 1 pleural puncture

• History of prior ipsilateral lung interventions including:

• Chest tube placement

• Surgery

• Pleurodesis

• Radiation treatment

Related Conditions & MeSH terms

• Lung Biopsy
• Pneumothorax

Intervention

Other:
• ABPI
If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.

Device:
• BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Rate of Pneumothorax	within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.	2 hours post procedure

External Links

•   Memorial Sloan Kettering Cancer Center