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"Asano, Fumihiro"
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Prospective multicenter validation of a next-generation sequencing panel using cytology specimens for lung cancer: cPANEL
2025
Background
There are no prospective studies to estimate whether cytology specimens can replace tissue samples using lung cancer gene panel analysis. We evaluated the success rate of gene panel testing and nucleic acid yield and quality when using cytology specimens for lung cancer over tissue specimens.
Methods
In this prospective study, clinical cytology specimens collected via transbronchial brushing, needle aspiration washing, and pleural effusion were stored in a nucleic acid stabilizer. The primary endpoint was the superior success rate of gene analysis using cytology specimens over the conventional success rate using tissue specimens.
Results
The full analysis set included 248 cases. The success rate for gene panel analysis using cytology specimens was 98.4% (95% confidence interval (CI), 95.9–99.6%) with a positive concordance rate of 97.3% (95% CI, 90.7–99.7%) by other companion diagnostic kits. The median value for nucleic acid yield and quality (DNA/RNA integrated number) of cytology specimens was 546.0/426.5 ng and 9.2/4.7 for DNA/RNA, respectively. The Pearson correlation coefficient of variant allele frequency between tissue formalin-fixed and paraffin-embedded (FFPE) sample and cytology specimens for mutant cases was 0.815. The ratio of double-stranded to total DNA showed that cytology specimens were of significantly higher quality than FFPE specimens.
Conclusions
The success rate of cytology specimens in gene analysis was significantly higher than conventional data. Because of the sufficient nucleic acid yield, high quality, and high correlation of mutant allele frequency compared to FFPE specimens, cytology specimens are suitable for panel testing as tissue substitutes.
Trial registration
UMIN Registry UMIN000047215 (cPANEL trial).
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053766
.
Journal Article
Virtual Bronchoscopic Navigation for Peripheral Pulmonary Lesions
by
Herth, Felix J.F.
,
Asano, Fumihiro
,
Eberhardt, Ralf
in
Bronchoscopy
,
Humans
,
Image-Guided Biopsy
2014
Virtual bronchoscopic navigation (VBN) is a method in which the bronchoscope is guided on the bronchial route to a peripheral lesion using virtual bronchoscopic images. In reports on VBN for peripheral pulmonary lesions searched in PubMed as of November 2013, the diagnostic yield by ultrathin bronchoscopy in combination with computed tomography and VBN was within the range of 65.4-81.6%. Using endobronchial ultrasonography with a guide sheath (EBUS-GS) and VBN, it was between 63.3 and 84.4%, and using X-ray fluoroscopy and VBN, it was between 62.5 and 78.7%. The overall diagnostic yield was 73.8% [95% confidence interval (CI) 70.9-76.8%] and that for lesions ≤2 cm was 67.4% (95% CI 63.3-71.5%). These values indicate high diagnostic rates. In randomized comparative trials, the combination of VBN with EBUS-GS improved the diagnostic yield and shortened the examination time. The diagnostic yields for lesions in the right upper lobe, those invisible on posterior-anterior radiographs and those located in the peripheral third of the lung field were improved by VBN on ultrathin bronchoscopy in combination with X-ray fluoroscopy. The usefulness of VBN was also found on meta-analysis. Taken together, VBN is a promising navigational bronchoscopy method as it requires no specific training, has a low overall complication rate of 1.0% (95% CI 0.2-1.8%) and does not directly induce or cause severe complications. To maximize the full potential of VBN and promote its use, investigation of cases in which it is useful, determination of the optimum combination of procedures, a cost/benefit analysis and advancement of the VBN system are warranted.
Journal Article
Close-to-lesion transbronchial biopsy: a novel technique to improve suitability of specimens for genetic testing in patients with peripheral pulmonary lesions
2023
Bronchoscopy with radial-probe endobronchial ultrasound, a guide sheath, and electromagnetic navigation can improve the diagnostic yield of peripheral lung nodules. However, the suitability of specimens for genetic analysis remains unsatisfactory. We hypothesized that a transbronchial biopsy performed after closely approaching the bronchoscope tip to the lesion might provide more suitable specimens for genetic analysis. We enrolled 155 patients with peripheral pulmonary lesions who underwent bronchoscopy with a thin or ultrathin bronchoscope. Bronchoscopy was performed using virtual bronchoscopic navigation and radial-probe endobronchial ultrasound with a guide sheath. The bronchoscope tip was placed closer to the lesion during bronchoscopy to collect larger specimens with higher malignant cell content. The patients who underwent a close-to-lesion biopsy had higher rates of overall diagnostic yield, histopathological diagnostic yield, and specimen quality for genetic testing than those who did not. The significant determinants of the specimen’s suitability were the close-to-lesion approach, within-the-lesion image, the use of standard 1.9-mm-forceps, and the number of cancer-cell-positive specimens. The significant predictors of the specimen’s suitability for genetic analysis were close-to-lesion biopsy and the number of malignant cell-positive tissue samples. This study demonstrates that the close-to-lesion transbronchial biopsy significantly improves the suitability of bronchoscopic specimens for genetic analysis.
Journal Article
Virtual bronchoscopic navigation without X-ray fluoroscopy to diagnose peripheral pulmonary lesions: a randomized trial
2017
Background
Transbronchial biopsy for peripheral pulmonary lesions is generally performed under X-ray fluoroscopy. Virtual bronchoscopic navigation (VBN) is a method in which virtual images of the bronchial route to the lesion are produced based on CT images obtained before VBN, and the bronchoscope is guided using these virtual images, improving the diagnostic yield of peripheral pulmonary lesions. VBN has the possibility of eliminating the need for X-ray fluoroscopy in the bronchoscopic diagnosis of peripheral lesions. To determine whether VBN can be a substitute for X-ray fluoroscopy, a randomized multicenter trial (non-inferiority trial) was performed in VBN and X-ray fluoroscopy (XRF) -assisted groups.
Methods
The non-inferiority margin in the VBN-assisted group compared with the XRF-assisted group was set at 15%. The subjects consisted of 140 patients with peripheral pulmonary lesions with a mean diameter > 3 cm. In the VBN-assisted group, the bronchoscope was guided to the lesion using a VBN system without X-ray fluoroscopy. In the XRF-assisted group, the same bronchoscope was guided to the lesion under X-ray fluoroscopy. Subsequently, in both groups, the lesion was visualized using endobronchial ultrasonography with a guide sheath (EBUS/GS), and biopsy was performed. In this serial procedure, X-ray fluoroscopy was not used in the VBNA group.
Results
The subjects of analysis consisted of 129 patients. The diagnostic yield was 76.9% (50/65) in the VBN-assisted group and 85.9% (55/64) in the XRF-assisted group. The difference in the diagnostic yield between the two groups was -9.0% (95% confidence interval: -22.3% ~ 4.3%). The non-inferiority of the VBN-assisted group could not be confirmed. The rate of visualizing lesions by EBUS was 95.4% (62/65) in the VBN-assisted group and 96.9% (62/64) in the XRF-assisted group, being high in both groups.
Conclusions
On EBUS/GS, a bronchoscope and biopsy instruments may be guided to the lesions using VBN without X-ray fluoroscopy, but X-ray fluoroscopy is necessary to improve the accuracy of sample collection from lesions. During transbronchial biopsy for peripheral pulmonary lesions, VBN cannot be a substitute for X-ray fluoroscopy.
Trial registration
UMIN-CTR (UMIN000001710); registered 16 February 2009.
Journal Article
A Virtual Bronchoscopic Navigation System for Pulmonary Peripheral Lesions
by
Asano, Fumihiro
,
Yamazaki, Koichi
,
Matsuno, Yoshihiko
in
Adult
,
Aged
,
Biological and medical sciences
2006
We performed ultrathin bronchoscopy for pulmonary peripheral lesions using a system that displays virtual bronchoscopy (VB) images to the lesion simultaneously with actual images and navigates the bronchoscope to the target bronchus. We then evaluated the system with regard to its usefulness and problems.
A pilot study.
A tertiary teaching hospital.
The subjects were consecutive patients with small pulmonary peripheral lesions (≤ 30 mm).
Using this system, the rotation, advancement, and retreat of VB images were possible, and the bronchus into which the bronchoscope was to be advanced was displayed. VB images were displayed along with actual images, and the ultrathin bronchoscope was advanced to the target bronchus under direct vision. Under CT and radiographic fluoroscopy, a pair of forceps was inserted into the lesion via the bronchoscope. Thin-section CT images were obtained; after confirming the advancement of the bronchoscope into the target bronchus and the arrival of the forceps at the lesion, a biopsy was performed.
Study subjects included 37 patients with 38 lesions. VB images to a median of the sixth- (third- to ninth-) order bronchi could be produced. Using this system, the ultrathin bronchoscope could be advanced into the planned route for 36 of the 38 lesions (94.7%). The system was used for a median of 2.6 min, and the median examination time was 24.9 min. The biopsy forceps could be advanced to the lesion in 33 of the 38 lesions (86.8%), and diagnosis was possible for 31 lesions (81.6%).
This navigation system is useful for ultrathin bronchoscopy for pulmonary peripheral lesions.
Journal Article
Factors leading to failure to diagnose pulmonary malignant tumors using endobronchial ultrasound with guide sheath within the target lesion
2019
Background
The diagnostic yield of peripheral pulmonary lesions has significantly increased with the use of radial endobronchial ultrasound with guide sheath within the lesion. Here, we retrospectively evaluated factors leading to misdiagnosis of pulmonary malignant tumors using endobronchial ultrasound with the guide sheath within the lesion.
Methods
We assessed the final histopathological diagnosis of biopsy samples taken from 130 patients with lung malignant tumors that underwent endobronchial ultrasound with guide sheath within the lesion.
Results
Among 130 patients, 8 (6%) showed no definite malignant findings in biopsy samples but the presence of malignant cells (primary lung cancer 7, diffuse large B cell lymphoma 1) was subsequently confirmed by histopathological study of specimens taken by computed tomography-guided needle biopsy or surgery. Of the eight cases with diagnostic failure, the size of the biopsy sample was insufficient in five due to technical difficulties during the diagnostic procedure, and the diagnosis of malignant tumor was difficult in five cases because of extensive scarring tissue or central necrosis.
Conclusions
The results of this study showed that technical difficulties and/or pathological heterogeneity of the tumor might lead to failure to diagnose lung malignant tumor in cases using endobronchial ultrasound with guide sheath within the lesion.
Journal Article
Evaluating the one-time chair stand test for predicting the coronavirus disease severity in patients during hospital admission: a cohort study in Japan
2023
BackgroundThis study aimed to understand whether the one-time chair stand test (CS-1) is useful for predicting the severity of coronavirus disease (COVID-19) in 101 patients admitted to the hospital with acute respiratory failure.MethodsThis single-centered, prospective observational cohort study enrolled 101 critically ill adult patients hospitalized with COVID-19 who underwent the CS-1 as a dynamic evaluation tool in clinical practice between late April 2020 and October 2021. Data on demographic characteristics, symptoms, laboratory values, computed tomography findings, and clinical course after admission were collected. Furthermore, the data was compared, and the association between the intubation and non-intubation groups was determined. We also calculated the cutoff point, area under the curve (AUC), and 95% confidence interval (CI) of the change in oxygen saturation (ΔSpO2) during the CS-1.ResultsThirty-three out of 101 patients (33%) were intubated during hospitalization. There was no significant difference in the resting SpO2 (93.3% versus 95.2%, P = 0.22), but there was a significant difference in ΔSpO2 during the CS-1 between the intubation and non-intubation groups (10.8% versus 5.5%, P < 0.01). In addition, there was a significant correlation between hospitalization and ΔSpO2 during the CS-1 (ρ = 0.60, P < 0.01). The generated cutoff point was calculated as 9.5% (AUC = 0.94, 95% CI = 0.88–1.00).ConclusionFor COVID-19 patients with acute respiratory failure, the CS-1 performed on admission was useful for predicting the severity of COVID-19. Furthermore, the CS-1 can be utilized as a remote and simple evaluation parameter. Thus, it could have potential clinical applications in the future.
Journal Article
Transbronchial Biopsy Using Endobronchial Ultrasonography With a Guide Sheath and Virtual Bronchoscopic Navigation
2005
We evaluated the feasibility, safety, and efficacy of transbronchial biopsy (TBB) using endobronchial ultrasonography with a guide sheath (EBUS-GS) and virtual bronchoscopy (VB) navigation for small peripheral pulmonary lesions ≤ 30 mm in diameter.
Pilot study.
A national university hospital.
We performed TBB using EBUS-GS with VB navigation for 29 patients with 30 small peripheral pulmonary lesions (average diameter, 18.6 mm) between January 1, 2004, and August 31, 2004.
VB images were reconstructed from helical CT data. TBB was then performed using EBUS-GS with VB navigation.
In all patients, TBB was performed safely with no complications. Bronchi seen on VB imaging were highly consistent with the actual structures confirmed using fiberoptic bronchoscopy. Following VB navigation, the endobronchial ultrasonography (EBUS) probe was inserted into third-to sixth-generation bronchi. Twenty-four lesions (80%) were visualized on EBUS images. Average durations of the initial EBUS examination of lesions, first biopsy, and the total procedure were 9.56 min, 11.99 min, and 25.72 min, respectively. Nineteen lesions (63.3%) were diagnosed from histopathologic or cytologic examination. Diagnostic sensitivities were 44.4% (8 of 18) for lesions < 20 mm in mean diameter and 91.7% (11 of 12) for lesions 20 to 30 mm in mean diameter.
In summary, TBB using EBUS-GS with VB navigation was safely performed and was effective in diagnosing small peripheral pulmonary lesions.
Journal Article
Use of Ultrathin Bronchoscope on a Need Basis Improves Diagnostic Yield of Difficult-to-Approach Pulmonary Lesions
2020
There are cases of peripheral lung nodules that are difficult to approach despite using ancillary diagnostic devices during multimodal bronchoscopy. The use of ultrathin bronchoscopes has shown superiority over standard thin bronchoscopes. We retrospectively evaluated whether substitution of the thin-bronchoscope by the ultrathin device during multimodal bronchoscopy improves lesion ultrasound visualization and diagnostic yield in patients with difficult-to-approach pulmonary lesions. The study comprised 44 out of 338 patients that underwent multimodal bronchoscopy at Matsusaka Municipal Hospital. The thin-bronchoscope with an external diameter of 4 mm was substituted by the ultrathin-bronchoscope with an external diameter of 3 mm when the radial endobronchial ultrasound showed that the probe position was not within the target lesion. The median diameter of the pulmonary tumors was 17.5 mm (range: 6.0–5.2.0 mm). The endobronchial ultrasound showed the probe's position adjacent to the lesion in 12 cases and no visible lesion in 32 cases using a thin-bronchoscope. However, the endobronchial ultrasound views changed from adjacent to the lesion to within the lesion in nine cases, from no visible lesion to within the lesion in 17 cases, and from no visible lesion to adjacent to the lesion in nine cases after bronchoscope substitution. After substitution, the diagnostic yield was 80.8% in cases with the radial probe within the target lesion, 72.7% in cases with the probe adjacent to the target lesion, and 0% in cases with no visible lesion. The overall diagnostic yield was 65.9% after bronchoscope substitution. The substitution of the thin bronchoscope by the ultrathin device on a need basis improves the position of the radial endobronchial ultrasound probe and diagnostic yield of pulmonary lesions during multimodal diagnostic bronchoscopy.
Journal Article