Evidence map›Paper›PMID 41249019›Full record

Observational studyThorax2025

Balloon dilatation for bronchoscope delivery: first-in-human trial of a novel technique for peripheral lung field access.

Kotaro Miyake, Masahide Oki, Hidekazu Suzuki, Hideo Saka, Shinji Sasada, Norio Okamoto, Tatsuya Imabayashi, Yoshihito Kogure, Takayuki Shiroyama, Haruhiko Hirata and 3 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Thorax, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
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

13 authors.

Kotaro MiyakeDepartment of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, University of Osaka, Suita, Osaka Prefecture, Japan kotaromiyake@imed3.med.osaka-u.ac.jp.ORCID 0000-0002-6441-1699
Masahide OkiNational Hospital Organization Nagoya Medical Center, Nagoya, Aichi Prefecture, Japan.
Hidekazu SuzukiDepartment of Thoracic Oncology, Osaka Habikino Medical Center, Habikino, Osaka Prefecture, Japan.ORCID 0000-0001-9067-1374
Hideo SakaMatsunami General Hospital, Hashima District, Gifu Prefecture, Japan.
Shinji SasadaDepartment of Respiratory Medicine, Fraternity Memorial Hospital, Sumida, Tokyo, Japan.
Norio OkamotoSakai City Hospital Organisation, Sakai, Osaka Prefecture, Japan.
Tatsuya ImabayashiJapanese Red Cross Kyoto Daiichi Hospital, Kyoto, Kyoto Prefecture, Japan.ORCID 0000-0002-6343-5306
Yoshihito KogureDepartment of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi Prefecture, Japan.
Takayuki ShiroyamaDepartment of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, University of Osaka, Suita, Osaka Prefecture, Japan.
Haruhiko HirataDepartment of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, University of Osaka, Suita, Osaka Prefecture, Japan.
Izumi NagatomoHealth and Counselling Centre, University of Osaka, Suita, Osaka Prefecture, Japan.ORCID 0000-0001-5382-4327
Yoshito TakedaDepartment of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, University of Osaka, Suita, Osaka Prefecture, Japan.
Atsushi KumanogohDepartment of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, University of Osaka, Suita, Osaka Prefecture, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBronchoscopic limitations in reaching peripheral pulmonary lesions (PPLs) can compromise biopsy sensitivity, especially for small PPLs. Therefore, we developed the balloon dilatation for bronchoscope delivery (BDBD) technique to dilate bronchial pathways and facilitate bronchoscope advancement into the periphery. This study evaluated the diagnostic performance and safety profile of transbronchial biopsy using this technique.

methodsThis multicentre, single-arm, prospective study included patients with bronchus sign-positive PPLs measuring <20 mm. Bronchoscopy was performed using ultrathin or thin bronchoscopes under conscious sedation. When the bronchoscope could not advance further, the BDBD technique was used to approach closer to the target, followed by biopsies. The primary endpoint was the diagnostic sensitivity for malignancy in specimens obtained through the specified procedure, defined as bronchoscope advancement using balloon dilatation, direct biopsy site visualisation and absence of serious adverse events.

resultsEighteen of 22 patients who underwent bronchoscopy with the BDBD technique were ultimately diagnosed with cancer. BDBD enabled bronchoscope advancement in all 18 cases without serious complications, allowed direct biopsy site visualisation in 17 and detected cancer in 14. Thus, the diagnostic sensitivity for malignancy was 77.8% (14/18). Beyond these cases, one patient who met all procedural criteria was diagnosed with cryptococcosis. Another patient was diagnosed with cancer without direct visualisation. On average, BDBD enabled bronchoscope advancement by 2.3 bifurcations.

conclusionIn this small observational study, BDBD appeared to be a promising technique for improving the diagnostic sensitivity of bronchoscopy for small PPLs. Further validation is necessary in large cohorts. TRIAL REGISTRATION NUMBER: jRCT2052220174.

Indexed as

BronchoscopesBronchoscopyDilatationLung NeoplasmsAdultAgedAged, 80 and overBiopsyFemaleHumansMaleMiddle AgedProspective StudiesBronchoscopyLung Cancer

Identifiers

PMID41249019
PMCPMC12772591

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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.