Evidence map›Paper›PMID 40419109›Full record

Trial reportChest2025

Ultrathin Bronchoscopy With Radial Endobronchial Ultrasound and Rapid On-Site Evaluation for the Diagnosis of Peripheral Pulmonary Lesions: A Multicenter Randomized Controlled Factorial Trial.

Erik Vakil, Marc Fortin, Anne V Gonzalez, Laïla Samy, Alex C Chee, Elaine Dumoulin, Marie Dvorakova, Christopher A Hergott, Moosa Khalil, Noël Lampron and 7 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Chest, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03809169 (Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03809169 nacompletednot on this map

Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial

TypeinterventionalSponsorUniversity of CalgaryRan2019 to 2024Enrolled186ConditionsPeripheral Pulmonary Lesions, Lung CancerArmsRapid on-site evaluation (ROSE), Slim bronchoscope without a guide sheath, Standard pEBUS with guide sheath
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Erik VakilDivision of Respirology, University of Calgary, Calgary, AB. Electronic address: erik.vakil@ucalgary.ca.
Marc FortinDepartment of Medicine, Université Laval, Quebec City, QC, Canada.
Anne V GonzalezDivision of Respirology, University of Calgary, Calgary, AB; Division of Respiratory Medicine, McGill University Health Centre, Montreal, QC, Canada.
Laïla SamyDepartment of Medicine, Université de Montréal, Montreal, QC, Canada.
Alex C CheeDivision of Respirology, University of Calgary, Calgary, AB.
Elaine DumoulinDivision of Respirology, University of Calgary, Calgary, AB.
Marie DvorakovaDepartment of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB.
Christopher A HergottDivision of Respirology, University of Calgary, Calgary, AB.
Moosa KhalilDepartment of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB.
Noël LampronDepartment of Medicine, Université Laval, Quebec City, QC, Canada.
Paul MacEachernDivision of Respirology, University of Calgary, Calgary, AB.
Simon MartelDepartment of Medicine, Université Laval, Quebec City, QC, Canada.
Benjamin ShiehDivision of Respiratory Medicine, McGill University Health Centre, Montreal, QC, Canada.
Mathieu SimonDepartment of Medicine, Université Laval, Quebec City, QC, Canada.
Thibaud SoumagneDepartment of Respiratory Medicine, Intensive Care and Bronchoscopy, European Hospital Georges Pompidou, APHP, Paris, France.
Tatjana TerzicDepartment of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB.
Alain TremblayDivision of Respirology, University of Calgary, Calgary, AB.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe routine use of CT imaging and lung cancer screening has increased the identification of peripheral pulmonary lesions (PPLs). Sampling may be needed for some nodules. Many new technologies are available to improve the diagnostic performance of bronchoscopy for the sampling of PPLs, but few comparative trials exist. The objective of this study was to compare the diagnostic performance of bronchoscopy with radial endobronchial ultrasound (rEBUS) using an ultrathin bronchoscope (BF-MP190F; Olympus) with a non-ultrathin bronchoscope and to compare the diagnostic performance of bronchoscopy with and without rapid on-site evaluation (ROSE). RESEARCH QUESTION: Does diagnostic performance differ between ultrathin and non-ultrathin bronchoscopes with rEBUS, and what impact does ROSE have on diagnostic performance of rEBUS? STUDY DESIGN AND

methodsThis pragmatic, multicenter, 2 × 2 factorial, randomized controlled trial involved adult patients with PPLs (mean diameter < 5 cm) and radiographic stage N0 disease referred for bronchoscopy. The study was powered to detect a 20% improvement in the primary outcome of difference in diagnostic yield (DY) between ultrathin and non-ultrathin bronchoscopes and between procedures with and without ROSE. Secondary outcomes included sensitivity for malignancy, complications, and procedure duration.

resultsOf 215 patients assessed, 186 patients were randomized and 181 patients were analyzed. Malignancy prevalence was 84%. No significant differences in DY or sensitivity for malignancy were found between non-ultrathin and ultrathin bronchoscopes: 65.6% vs 58.2% (difference, -7.3%; P = .36) and 84.3% vs 74.3% (difference, -10.0%; P = .21), respectively. Similarly, no significant differences were observed with or without ROSE: 60.4% vs 63.5% (difference, -3.1%; P = .76) and 80.3% vs 78.3% (difference, 2.0%; P = .83), respectively.

interpretationWe could not identify a difference in DY or sensitivity for malignancy for the diagnosis of PPLs between an ultrathin bronchoscope and a non-ultrathin bronchoscope and between ROSE and no ROSE. The study was underpowered to detect smaller but potentially clinically meaningful differences. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT03809169; URL: www. CLINICALTRIALS: gov.

Indexed as

BronchoscopyEndosonographyLung NeoplasmsRapid On-site EvaluationAgedBronchoscopesFemaleHumansMaleMiddle Agedbronchoscopy methodsendobronchial ultrasoundlung neoplasm diagnosisneedle biopsy methodspulmonary nodule diagnosis

Identifiers

PMID40419109
PMCPMC12597412

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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.