Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05059691

Collaborator

(none)

Enrollment

Location

21.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Carcinoma	Other: Electronic Health Record Review Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVE:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 30, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational (transbronchial cryobiopsy) Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.	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

Arm

Intervention/Treatment

Observational (transbronchial cryobiopsy)

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

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

Outcome Measures

Primary Outcome Measures

Incidence of pneumothorax [Up to 72 hours after cryobiopsy]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Bruce F Sabath, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

MD Anderson Cancer Center Website

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05059691

Other Study ID Numbers:

2020-1174
NCI-2021-08947
2020-1174

First Posted:

Sep 28, 2021

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Aug 22, 2022