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

Phase 3

Completed

• Conditions: Lung Biopsy
• Interventions: Other: ABPI; Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug

• Registration Number: NCT02224924
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08-21
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Status Verified: 2023-01
• Primary Completion: 2023-01-11
• Study Completion: 2023-01-11
• Results First Submitted: 2024-01-05
• Results First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous blood patch injection (ABPI)	ABPI	-
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug	BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug	-

Primary Outcome Measures

Name	Time	Method
the Rate of Pneumothorax	2 hours post procedure	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.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States