Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (transbronchial cryobiopsy)

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

Electronic Health Record Review

Intervention Type OTHER

Review of medical records

Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy

Intervention Type PROCEDURE

Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy

Interventions

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Electronic Health Record Review

Review of medical records

Intervention Type OTHER

Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy

Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No