Clinical trial NCT02224924: Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Official title: Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Biopsy
Keywords: Experimental: autologous blood patch injection (ABPI)
Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
14-141
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the Rate of Pneumothorax
timeFrame: 2 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amgad Moussa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.