Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

NCT05059691 | Completed

• 2 other identifiers: 2020-1174NCI-2021-08947
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational (transbronchial cryobiopsy)

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

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

Interventions

Electronic Health Record Review OTHER

Review of medical records

Observational (transbronchial cryobiopsy)

Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy PROCEDURE

Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy

Observational (transbronchial cryobiopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bruce F Sabath

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 28, 2021
• Study Start: March 30, 2021
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

US (1)