Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

M.D. Anderson Cancer Center

Status: Completed

Conditions: Lung Carcinoma

Treatments: Other: Electronic Health Record Review; Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05059691

2020-1174 (Other Identifier)

NCI-2021-08947 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Observational (transbronchial cryobiopsy)

Description:

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

Treatment:

Other: Electronic Health Record Review

Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy