Evidence map›Paper›PMID 30958102›Full record

Observational studyTherapeutic advances in respiratory disease

Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study.

Mark R Bowling, Erik E Folch, Sandeep J Khandhar, Jordan Kazakov, William S Krimsky, Gregory P LeMense, Philip A Linden, Boris A Murillo, Michael A Nead, Michael A Pritchett and 4 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02410837 (NAVIGATE), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02410837 completednot on this map

NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

Typeobservational_patient_registrySponsorMedtronic - MITGRan2015 to 2019Enrolled1,388ConditionsLung Lesion(s) Requiring EvaluationArmsElectromagnetic Navigation Bronchoscopy
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. CyberKnifeJournal of thoracic disease · 2023
    Article
  6. Article
  7. Article
  8. Fiducial markers for stereotactic lung radiation therapy: review of the transthoracic, endovascular and endobronchial approaches.European respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. A visual SLAM-based bronchoscope tracking scheme for bronchoscopic navigation.International journal of computer assisted radiology and surgery · 2020
    Article
  15. Article
  16. Interventional Pulmonology: A Brave New World.Thoracic surgery clinics · 2020
    Review
  17. [Advances of Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2020
    Review
  18. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Mark R BowlingDepartment of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, 521a Moye Boulevard, Greenville, NC 27834, USA.ORCID 0000-0002-3490-5647
Erik E FolchMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Sandeep J KhandharInova Health System, Virginia Cancer Specialists, Fairfax, VA, USA.
Jordan KazakovUniversity Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, OH, USA.
William S KrimskyMedstar Franklin Square Hospital Center, Baltimore, MD, USA.
Gregory P LeMenseBlount Memorial Physicians Group, Maryville, TN, USA.
Philip A LindenUniversity Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, OH, USA.
Boris A MurilloProvidence Health Center, Waco, TX, USA.
Michael A NeadUniversity of Rochester Medical Center, Rochester NY, USA.
Michael A PritchettPulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, NC, USA.
Catalina V TebaUniversity Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, OH, USA.
Christopher W ToweUniversity Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, OH, USA.
Terence WilliamsDepartment of Radiation Oncology, Ohio State University Wexner Medical Center, Columbus OH, USA Brigham and Women's Hospital, Boston, MA, USA.
Carlos J AncianoEast Carolina University, Greenville, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB).

methodsNAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24 months is ongoing.

resultsTwo-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0 min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 ± 1.7 FMs (median 1.0 FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade ⩾ 2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade ⩾ 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages.

conclusionENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study.

trial registrationClinicalTrials.gov identifier: NCT02410837.

Indexed as

Electromagnetic PhenomenaFiducial MarkersAdultAgedAged, 80 and overBiopsyBronchoscopyCohort StudiesEndosonographyFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedPneumothoraxelectromagnetic navigation bronchoscopyfiduciallung cancerprospective clinical studystereotactic body radiation therapy

Identifiers

PMID30958102
PMCPMC6454637

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.