Clinical trial NCT05059691: Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy
Official title: Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy, a Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy

Brief summary: This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.

Detailed description: PRIMARY OBJECTIVE:

I. To determine if transbronchial cryobiopsy guided by three-dimensional fluoroscopy reduces the incidence of pneumothorax up to 72 hours after transbronchial cryobiopsy.

SECONDARY OBJECTIVE:

I. To describe outcomes of cryobiopsy, need for interventions related to transbronchial cryobiopsy, radiation dose, and any complications or adverse events after transbronchial cryobiopsy guided by three-dimensional fluoroscopy.

OUTLINE:

Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
* Ability to provide informed consent

Exclusion Criteria:

* Acute respiratory failure (defined as oxygen requirement \> 4 L/min by nasal cannula above baseline, or need for any intervention to support ventilation and/or gas exchange for any duration, including invasive and non-invasive positive pressure ventilation, high-flow therapy, non-rebreather mask, or Venturi mask)
* Intensive care unit (ICU) admission
* Forced vital capacity (FVC) \< 50% or diffusing capacity of the lung for carbon monoxide (CO) (DLCO) \< 35% (if pulmonary function tests are available)
* Known or suspected pulmonary hypertension (defined as elevated right ventricular systolic pressure on echocardiogram, if available)
* Acute renal failure or chronic kidney disease
* Platelets \< 100,000/uL
* International normalized ratio (INR) \> 1.5
* Use of anticoagulant therapy that cannot be held for 2 days
* Use of antiplatelet therapy (other than baby aspirin) that cannot be held for 5 days
* Any bleeding diathesis
* Pregnancy

Primary outcomes:
measure: Incidence of pneumothorax
timeFrame: Up to 72 hours after cryobiopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Bruce F Sabath
role: PRINCIPAL_INVESTIGATOR
References: