Lung Biopsy
Conditions
Keywords
Experimental: autologous blood patch injection (ABPI), Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug, 14-141
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.
Interventions
OTHERABPI
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.
DEVICEBioSentry (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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Autologous Blood Patch Injection (ABPI) 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. | 226 |
| BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug 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. | 227 |
| Total | 453 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Biopsy cancelled | 20 | 14 |
| Overall Study | Intra procedural exclusion - sealant deployed | 23 | 11 |
| Overall Study | Intra procedural exclusion - sealant not deployed | 20 | 35 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Autologous Blood Patch Injection (ABPI) | Total | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug |
|---|---|---|---|
| Age, Continuous | 66.8 years | 67 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 21 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 328 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 51 Participants | 104 Participants | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 27 Participants | 15 Participants |
| Race (NIH/OMB) White | 188 Participants | 378 Participants | 190 Participants |
| Region of Enrollment United States | 226 Participants | 453 Participants | 227 Participants |
| Sex: Female, Male Female | 124 Participants | 251 Participants | 127 Participants |
| Sex: Female, Male Male | 102 Participants | 202 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 226 | 0 / 228 |
| other Total, other adverse events | 0 / 226 | 0 / 228 |
| serious Total, serious adverse events | 0 / 226 | 0 / 228 |
Outcome results
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.
Time frame: 2 hours post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Autologous Blood Patch Injection (ABPI) | the Rate of Pneumothorax | Experienced pneumothorax within 2 hours post procedure | 42 Participants |
| Autologous Blood Patch Injection (ABPI) | the Rate of Pneumothorax | Did not experience pneumothorax within 2 hours post procedure | 184 Participants |
| BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | the Rate of Pneumothorax | Experienced pneumothorax within 2 hours post procedure | 60 Participants |
| BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | the Rate of Pneumothorax | Did not experience pneumothorax within 2 hours post procedure | 168 Participants |