Chinese expert consensus on technical specifications of electromagnetic navigation bronchoscopy in diagnosing peripheral pulmonary lesions.
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SUBMITTER: Xie F
PROVIDER: S-EPMC8107541 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Chinese expert consensus on technical specifications of electromagnetic navigation bronchoscopy in diagnosing peripheral pulmonary lesions.
Xie Fangfang F Yang Huaping H Huang Rui R Zheng Xiaoxuan X Cao Liming L Liu Jingjing J Qu Shuoyao S Zhang Yan Y Wu Shiman S Zhang Jian J Ke Mingyao M Sun Jiayuan J
Journal of thoracic disease 20210401 4
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Project description:BackgroundBronchoscopic diagnosis of small peripheral lung lesions suspected of lung cancer remains a challenge. A successful endobronchial diagnosis comprises navigation, confirmation, and tissue acquisition. In all steps, 3-dimensional information is essential. Cone-beam computed tomography (CBCT) imaging can provide computed tomography information and 3-dimensional augmented fluoroscopy imaging. We assessed whether CBCT imaging can improve navigation and diagnosis of peripheral lesions by 2 clinical workflows with a cross-over design: (1) a primary CBCT and radial endobronchial ultrasound mini probe imaging-based approach and (2) a primary electromagnetic navigation (EMN) and radial endobronchial ultrasound mini probe imaging-based approach.MethodsAll patients with a peripheral lung lesion biopsy indication were eligible for study inclusion and randomly assigned to study arms. Commercially available equipment was used. The main study goals were to assess CBCT-confirmed navigation success and diagnostic accuracy. Surgery or unambiguous clinical follow-up served as the gold standard.ResultsEighty-seven patients with 107 lesions were included. Lesion mean longest axis size in the CBCT arm was 16.6 mm (n=47) and 14.2 mm in the EMN arm (n=40). The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively. Addition of EMN to the CBCT approach increased navigation success to 89.9%. Addition of CBCT imaging to the EMN approach significantly increased navigation success to 87.5% per lesion. The overall diagnostic accuracy per patient was significantly lower than the navigation success, being 72.4%.ConclusionCBCT imaging is a valuable addition to navigation bronchoscopy. Although overall navigation success was high, the diagnostic accuracy remains to be improved. Future research should focus on improving the tissue acquisition methodology.
| S-EPMC7742216 | biostudies-literature
Project description:RationaleElectromagnetic navigation bronchoscopy using superDimension/Bronchus System is a novel method to increase diagnostic yield of peripheral and mediastinal lung lesions.ObjectivesA prospective, open label, single-center, pilot study was conducted to determine the ability of electromagnetic navigation bronchoscopy to sample peripheral lung lesions and mediastinal lymph nodes with standard bronchoscopic instruments and demonstrate safety.MethodsElectromagnetic navigation bronchoscopy was performed using the superDimension/Bronchus system consisting of electromagnetic board, position sensor encapsulated in the tip of a steerable probe, extended working channel, and real-time reconstruction of previously acquired multiplanar computed tomography images. The final distance of the steerable probe to lesion, expected error based on the actual and virtual markers, and procedure yield was gathered.Measurements60 subjects were enrolled between December 2004 and September 2005. Mean navigation times were 7 +/- 6 min and 2 +/- 2 min for peripheral lesions and lymph nodes, respectively. The steerable probe tip was navigated to the target lung area in all cases. The mean peripheral lesions and lymph nodes size was 22.8 +/- 12.6 mm and 28.1 +/- 12.8 mm. Yield was determined by results obtained during the bronchoscopy per patient.ResultsThe yield/procedure was 74% and 100% for peripheral lesions and lymph nodes, respectively. A diagnosis was obtained in 80.3% of bronchoscopic procedures. A definitive diagnosis of lung malignancy was made in 74.4% of subjects. Pneumothorax occurred in two subjects.ConclusionElectromagnetic navigation bronchoscopy is a safe method for sampling peripheral and mediastinal lesions with high diagnostic yield independent of lesion size and location.
| S-EPMC2648102 | biostudies-literature
Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.MethodsNAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.ResultsENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.ConclusionsOne-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.Trial registrationClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
| S-EPMC5387322 | biostudies-literature
Project description:BackgroundThoracoscopic localization of small peripheral pulmonary nodules is a concern. Failure can lead to larger parenchymal resection or conversion to thoracotomy. This study evaluates our experience in preoperative electromagnetic navigation bronchoscopy-guided localization of small peripheral lung lesions.MethodsFrom January 2017 to March 2020 clinical, radiographic, surgical, and pathological data of patients who underwent electromagnetic navigation bronchoscopy (ENB)-guided methylene blue pleural marking of highly suspected pulmonary lesions before a full thoracoscopic resection were evaluated. Localization was performed for solid or mixed subpleural nodules measuring <10 mm, solid nodules measuring <20 mm located at more than 1 cm from the pleura and any pure ground glass opacity. Successful localization was defined as successful identification and thoracoscopic resection of target lesions.ResultsForty-eight patients were included: 30 solid nodules (63%), 12 pure GGO (25%) and 6 mixed (13%). The median largest diameter at CT-scan was 11 mm (IQR, 9-14 mm) while the median distance from the pleural surface was 12 mm (IQR, 6-16 mm). The median ENB length was 25 min (19-33 min). Localization procedure was successful in 45 cases (94%). No procedural-related complications were reported.ConclusionsENB is a safe and accurate preoperative procedure to localize small lung peripheral lesions. The high successful rate, the absence of related complications, the possibility of performing the procedure in the same operating room with a single general anesthesia, make ENB-guided dye marking an advantageous tool for thoracoscopic pulmonary resection.
| S-EPMC8339756 | biostudies-literature
Project description:BackgroundTo compare the diagnostic yield of peripheral pulmonary lesions (PPLs) with and without navigation system.MethodsStudies dating from January 1990 to October 2019 were collected from databases. Diagnostic yield of navigation bronchoscopy and non-navigation bronchoscopy was extracted from comparative studies. Subgroup analysis was adopted to test diagnostic yield variation by lesion size, lobe location of the lesion, distance from the hilum, bronchus sign and nature of the lesion.ResultsIn total, 2131 patients from 10 studies were enrolled into the study. Diagnostic yield of navigation bronchoscopy was statistically higher than non-navigation bronchoscopy for PPLs (odds ratio [OR] 1.69, 95% confidence interval [CI] 1.32, 2.18, P < 0.001), particularly for PPLs in the peripheral third lung (OR 2.26, 95% CI 1.48, 3.44, P < 0.001) and for bronchus sign positive PPLs (OR 2.26, 95% CI 1.21, 4.26, P = 0.011). Navigation bronchoscopy had better performance than non-navigation bronchoscopy when PPLs were ≤ 20 mm (OR 2.09, 95% CI 1.44, 3.03, P < 0.001). It also elevated diagnostic yield of malignant PPLs (OR 1.67, 95% CI 1.26, 2.22, P < 0.001) and PPLs in the bilateral upper lobes (OR 1.50, 95% CI 1.09, 2.08, P = 0.014).ConclusionsNavigation bronchoscopy enhanced diagnostic yield when compared to non-navigation bronchoscopy, particularly for PPLs in the peripheral third lung, PPLs being bronchus sign positive, PPLs ≤ 20 mm, malignant PPLs and PPLs in the bilateral upper lobes.Key pointsThe current study provided systematic evaluation on the diagnostic value of navigation bronchoscopy by comparing it with non-navigation bronchoscopy, and exploring the factors affecting the diagnostic yield.
| S-EPMC7180606 | biostudies-literature
Project description:Electromagnetic navigation bronchoscopy (ENB) has been demonstrated to increase the diagnostic yield of peripheral pulmonary lesions. We designed two prospective clinical trials using an innovative ENB system that can combine with both thick and thin bronchoscope, including a randomized controlled clinical study to assess the usefulness of the ENB system and a real-world study to explore the optimal way to use this system. Patients with peripheral pulmonary nodules (PPNs) suspicious of lung cancer with the long diameter more than 8 mm and no more than 30 mm will be enrolled in the study. A total of 400 patients will be enrolled in the randomized controlled clinical study and randomly divided into two groups, endobronchial ultrasound (EBUS) combined with guide sheath (GS) with or without ENB. The real-world study is a single arm and observational study, at least 750 subjects will be enrolled in the study. ENB combined with or without other guided bronchoscopy techniques, fluoroscopy, and rapid on-site cytologic evaluation (ROSE) will be performed according to the judgment of the operator. The primary endpoint of the two studies is the diagnostic yield of ENB in diagnosing PPNs. The secondary endpoint includes the diagnostic yields for malignant and benign diseases, navigation time, time for finding lesions, total operation time, complication rate, etc. Enrollment for the study began in July 2018 and is currently in progress. With up to 1,150 subjects estimated to be enrolled, the study will provide evidence on the usage of the novel ENB system in diagnosing PPNs.
| S-EPMC6988046 | biostudies-literature
Project description:Lung cancer is often diagnosed at an advanced stage and is associated with significant morbidity and mortality. Low-dose computed tomography for lung cancer screening has increased the incidence of peripheral pulmonary lesions. Surveillance and early detection of these lesions at risk of developing cancer are critical for improving patient survival. Because these lesions are usually distal to the lobar and segmental bronchi, they are not directly visible with standard flexible bronchoscopes resulting in low diagnostic yield for small lesions <2 cm. The past 30 years have seen several paradigm shifts in diagnostic bronchoscopy. Recent technological advances in navigation bronchoscopy combined with other modalities have enabled sampling lesions beyond central airways. However, smaller peripheral lesions remain challenging for bronchoscopic biopsy. This review provides an overview of recent advances in interventional bronchoscopy in the screening, diagnosis, and treatment of peripheral pulmonary lesions, with a particular focus on virtual bronchoscopic navigation.
| S-EPMC9588954 | biostudies-literature
Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) procedures allow physicians to access peripheral lung lesions beyond the reach of conventional bronchoscopy. However, published research is primarily limited to small, single-center studies using previous-generation ENB software. The impact of user experience, patient factors, and lesion/procedural characteristics remains largely unexplored in a large, multicenter study.Methods/designNAVIGATE (Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy) is a prospective, multicenter, global, cohort study. The study aims to enroll up to 2,500 consecutive subjects presenting for evaluation of lung lesions utilizing the ENB procedure at up to 75 clinical sites in the United States, Europe, and Asia. Subjects will be assessed at baseline, at the time of procedure, and at 1, 12, and 24 months post-procedure. The pre-test probability of malignancy will be determined for peripheral lung nodules. Endpoints include procedure-related adverse events, including pneumothorax, bronchopulmonary hemorrhage, and respiratory failure, as well as quality of life, and subject satisfaction. Diagnostic yield and accuracy, repeat biopsy rate, tissue adequacy for genetic testing, and stage at diagnosis will be reported for biopsy procedures. Complementary technologies, such as fluoroscopy and endobronchial ultrasound, will be explored. Success rates of fiducial marker placement, dye marking, and lymph node biopsies will be captured when applicable. Subgroup analyses based on geography, demographics, investigator experience, and lesion and procedure characteristics are planned.DiscussionStudy enrollment began in April 2015. As of February 19, 2016, 500 subjects had been enrolled at 23 clinical sites with enrollment ongoing. NAVIGATE will be the largest prospective, multicenter clinical study on ENB procedures to date and will provide real-world experience data on the utility of the ENB procedure in a broad range of clinical scenarios.Trial registrationClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
| S-EPMC4845335 | biostudies-literature
Project description:BackgroundCurrent medical society guidelines recommend a procedural number for obtaining electromagnetic navigational bronchoscopy (ENB) competency and for institutional volume for training.ObjectiveTo assess learning curves and estimate the number of ENB procedures for interventional pulmonology (IP) fellows to reach competency.MethodsWe conducted a prospective multicenter study of IP fellows in the United States learning ENB. A tool previously validated in a similar population was used to assess IP fellows by their local faculty and two blinded independent reviewers using virtual recording of the procedure. Competency was determined by performing three consecutive procedures with a competency score on the assessment tool. Procedural time, faculty global rating scale, and periprocedural complications were also recorded.ResultsA total of 184 ENB procedures were available for review with assessment of 26 IP fellows at 16 medical centers. There was a high correlation between the two blinded independent observers (rho = 0.8776). There was substantial agreement for determination of procedural competency between the faculty assessment and blinded reviewers (kappa = 0.7074; confidence interval, 0.5667-0.8482). The number of procedures for reaching competency for ENB bronchoscopy was determined (median, 4; mean, 5; standard deviation, 3.83). There was a wide variation in the number of procedures to reach competency, ranging from 2 to 15 procedures. There were six periprocedural complications reported, four (one pneumomediastinum, three pneumothorax) of which occurred before reaching competence and two pneumothoraces after achieving competence.ConclusionThere is a wide variation in acquiring competency for ENB among IP fellows. Virtual competency assessment has a potential role but needs further studies.
| S-EPMC9341475 | biostudies-literature
Project description:Background:With the aid of electromagnetic navigation bronchoscopy (ENB), it has become possible to approach peripheral lung tumors from the airway. Meanwhile, local ablation using photodynamic therapy (PDT) has shown increasing promise in the realm of lung cancer treatment. The purpose of this study was to explore an alternative ablation method using PDT with SuperDimension ENB localization in a hybrid operating theater. Methods:Our study includes patients with primary or metastatic lung cancer who underwent PDT via ENB in the hybrid operating room (OR) of National Taiwan University Hospital between January 2016 and January 2017. ENB with the SuperDimension Navigation System (7th edition) was performed before PDT ablation to localize the target lesions. PDT ablation was performed with the assistance of intraoperative Dyna-computed tomography (Dyna-CT). Tumor response was evaluated by CT 3 months after the procedure. Results:Three patients underwent lung interstitial PDT via the aid of ENB during the study period. The mean size of the nodules was 21.3 mm. The mean navigation time was 14.3 minutes. In all cases, the target pulmonary nodule was ablated by PDT successfully. No major procedure-related complications occurred. One patient suffered from skin hypersensitivity one month after the procedure. The follow-up CT showed significant tumor shrinkage for all the patients. They were all discharged without incident a few days after the procedure as scheduled. Conclusions:PDT with SuperDimension ENB guidance in the hybrid OR is a novel and feasible approach to control peripheral lung malignancy.
| S-EPMC5911748 | biostudies-literature