Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung NodulesTake-home Points

Robert J. Lentz, MD; Katherine Frederick-Dyer, MD; Virginia B. Planz, MD; Tatsuki Koyama, PhD; Matthew C. Aboudara, MD; Briana Swanner, BS; Lance Roller, MS; See-Wei Low, MD; Cristina Salmon, MD; Sameer K. Avasarala, MD; Todd C. Hoopman, MD; Momen M. Wahidi, MD; Kamran Mahmood, MD, MPH; George Z. Cheng, MD, PhD; James M. Katsis, MD; Jonathan S. Kurman, MD; Pierre-François D’Haese, PhD; Joyce Johnson, MD; Eric L. Grogan, MD, MPH; Charla Walston, AGACNP-BC; Lonny Yarmus, DO; Gerard A. Silvestri, MD; Otis B. Rickman, DO; Najib M. Rahman, DPhil; Fabien Maldonado, MD

CHEST Pulmonary (Sep 2024)

Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung NodulesTake-home Points

Robert J. Lentz, MD,
Katherine Frederick-Dyer, MD,
Virginia B. Planz, MD,
Tatsuki Koyama, PhD,
Matthew C. Aboudara, MD,
Briana Swanner, BS,
Lance Roller, MS,
See-Wei Low, MD,
Cristina Salmon, MD,
Sameer K. Avasarala, MD,
Todd C. Hoopman, MD,
Momen M. Wahidi, MD,
Kamran Mahmood, MD, MPH,
George Z. Cheng, MD, PhD,
James M. Katsis, MD,
Jonathan S. Kurman, MD,
Pierre-François D’Haese, PhD,
Joyce Johnson, MD,
Eric L. Grogan, MD, MPH,
Charla Walston, AGACNP-BC,
Lonny Yarmus, DO,
Gerard A. Silvestri, MD,
Otis B. Rickman, DO,
Najib M. Rahman, DPhil,
Fabien Maldonado, MD

Affiliations

Robert J. Lentz, MD: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN; Department of Veterans Affairs Medical Center, Nashville, TN
Katherine Frederick-Dyer, MD: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, TN
Virginia B. Planz, MD: Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, TN
Tatsuki Koyama, PhD: Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN
Matthew C. Aboudara, MD: Division of Pulmonary Critical Care Medicine, St. Luke’s Health System, University of Missouri at Kansas City, Kansas City, MO
Briana Swanner, BS: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN
Lance Roller, MS: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN
See-Wei Low, MD: Division of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, OH
Cristina Salmon, MD: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN
Sameer K. Avasarala, MD: Division of Pulmonary, Critical Care, and Sleep Medicine, University Hospitals—Case Western Reserve University School of Medicine, Cleveland, OH
Todd C. Hoopman, MD: Pulmonary and Critical Care, Kootenai Health, Coeur d’Alene, ID
Momen M. Wahidi, MD: Division of Pulmonary and Critical Care, Northwestern Feinberg School of Medicine, Chicago, IL
Kamran Mahmood, MD, MPH: Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, NC
George Z. Cheng, MD, PhD: Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, CA
James M. Katsis, MD: Division of Pulmonary and Critical Care Medicine, Rush University Medical Center, Chicago, IL
Jonathan S. Kurman, MD: Division of Pulmonary, Critical Care and Sleep Medicine, Medical College of Wisconsin, Milwaukee, WI
Pierre-François D’Haese, PhD: Vanderbilt University School of Engineering, Nashville, TN
Joyce Johnson, MD: Department of Pathology, Vanderbilt University Medical Center, Nashville, TN
Eric L. Grogan, MD, MPH: Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN; Department of Veterans Affairs Medical Center, Nashville, TN
Charla Walston, AGACNP-BC: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN
Lonny Yarmus, DO: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
Gerard A. Silvestri, MD: Division of Pulmonary, Critical Care, Allergy & Sleep Medicine, Medical University of South Carolina, Charleston, SC
Otis B. Rickman, DO: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN
Najib M. Rahman, DPhil: Oxford Respiratory Trials Unit, University of Oxford, Oxford, England; Oxford Chinese Academy of Medical Sciences Institute, University of Oxford, Oxford, England; Oxford NIHR Biomedical Research Centre, Oxford, England
Fabien Maldonado, MD: Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN; CORRESPONDENCE TO: Fabien Maldonado, MD

Journal volume & issue: Vol. 2, no. 3
p. 100050

Abstract

Read online

Background: Lung nodule incidence is increasing. Many nodules require biopsy to discriminate between benign and malignant causes. The gold standard for minimally invasive biopsy, CT scan-guided transthoracic needle biopsy (CT-TTNB), has not been compared directly with navigational bronchoscopy, a method that recently has seen rapid technological innovation and is associated with improving diagnostic yield and lower complication rates. Current estimates of the diagnostic usefulness of both methods are based largely on noncomparative data with significant risk for selection, referral, and publication biases. Research Question: Is contemporary navigational bronchoscopy noninferior to CT scan-guided transthoracic needle biopsy for the diagnosis of indeterminate pulmonary nodules? Study Design and Methods: Navigation Endoscopy to Reach Indeterminate Lung Nodules vs Transthoracic Needle Aspiration, a Randomized Controlled Study, is a multicenter, 1:1 randomized, parallel-group trial designed to ascertain whether electromagnetic navigational bronchoscopy with integrated digital tomosynthesis is noninferior to CT-TTNB for the diagnosis of peripheral lung nodules 10 to 30 mm in diameter with before testing probability of malignancy of at least 10%. The primary end point is diagnostic accuracy through 12 months of follow-up. Secondary end points include diagnostic yield, complication rate, procedure duration, need for additional invasive diagnostic procedures, and radiation exposure. Results: This article describes the protocol and rationale for the Navigation Endoscopy to Reach Indeterminate Lung Nodules vs Transthoracic Needle Aspiration, a Randomized Controlled Study, designed to answer the study question. Interpretation: The results of this rigorously designed trial will provide high-quality data regarding the management of lung nodules, a common clinical entity that often represents the earliest and most treatable stage of lung cancer. Several design challenges are described. Notably, all nodules are reviewed centrally by an independent interventional pulmonology and radiology adjudication panel relying on prespecified exclusions to ensure enrolled nodules are amenable to sampling by both methods while protecting against selection bias favoring either method. Conservative diagnostic yield and accuracy definitions with prespecified criteria for what nonmalignant findings may be considered diagnostic were chosen to avoid inflation of estimates of diagnostic usefulness. Trial Registry: ClinicalTrials.gov; No.: NCT04250194; URL: www.clinicaltrials.gov

Published in CHEST Pulmonary

ISSN: 2949-7892 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the respiratory system
Website: https://www.sciencedirect.com/journal/chest-pulmonary

About the journal

Abstract

Keywords