Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

Lung Carcinoma Clinical Trial

Official title:

Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy, a Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059691
• Other study ID #: 2020-1174
• Secondary ID: NCI-2021-0894720
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Electronic Health Record Review
Review of medical records

Procedure:
• Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy
Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pneumothorax	The proportion of patients developing pneumothorax will be compared with the proportion in the historical control (i.e., 20%) using two-sided binomial test. A p-value of less than 0.05 will indicate a statistical significance. The proportion of patients identified as developing pneumothorax and its exact 95% confidence interval will be estimated. Poisson regression model will be used to estimate the incidence of pneumothorax accounting for the number of biopsy sites.	Up to 72 hours after cryobiopsy

External Links

•   MD Anderson Cancer Center Website