Expanding the scope of electromagnetic navigation bronchoscopy-guided transbronchial biopsy and ablation with mobile 3D C-arm Machine Cios Spin®-feasibility and challenges.
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ABSTRACT:
SUBMITTER: Chan JWY
PROVIDER: S-EPMC8577978 | biostudies-literature | 2021 Oct
REPOSITORIES: biostudies-literature
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Expanding the scope of electromagnetic navigation bronchoscopy-guided transbronchial biopsy and ablation with mobile 3D C-arm Machine Cios Spin<sup>®</sup>-feasibility and challenges.
Chan Joyce W Y JWY Lau Rainbow W H RWH Chu Cheuk Man CM Ng Calvin S H CSH
Translational lung cancer research 20211001 10
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Project description:BackgroundTransbronchial ablation of lung nodules is gaining popularity as part of lung-preserving strategy for patients with multifocal lung cancers or multiple lung oligometastases. Accuracy in placement of ablation catheter is of utmost importance in order to achieve adequate ablation margin. However, older systems are not precise enough for confident placement of ablation catheter and often require multiple cone-beam CT (CBCT) to confirm and readjust its position. The following case is the first microwave lung ablation utilizing the novel IllumisiteTM platform (Medtronic, Minneapolis, MN, USA) in the hybrid operating room (HOR), with enhanced accuracy and workflow.Case descriptionA 66-year-old lady had multiple resected adenocarcinomas in bilateral lungs. Upon CT monitoring a right middle lobe (RML) ground glass opacity with solid centre was found to be suspicious due to increasing size and density. Transbronchial electromagnetic navigation bronchoscopy (ENB) microwave ablation of the lesion was performed as part of lung-conserving strategy. After initial navigation, the adjusted nodule position provided by the IllumisiteTM platform after correcting the CT-to-body divergence prompted operators to renavigate and readjust the position of the locatable guide (LG) swiftly to gain accurate access to the nodule, which was confirmed by CBCT. Positional data at the tip of extended working channel (EWC) also allowed precise placement of needle for subsequent ablation.ConclusionsIllumisiteTM is a novel electromagnetic navigational platform that corrects for CT-to-body divergence and ensures continuous locational information by an additional positional coil in the tip of EWC. This precision is especially important for the placement of ablation catheter, as slight deviation would lead to insufficient ablation margin and future recurrence. Workflow is improved by reducing the number of CBCT required for instrument position adjustment.
| S-EPMC10130683 | 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 a useful method to obtain tissue for peripheral lung nodules. We aimed to understand the diagnostic yield and safety profile in high-risk pulmonary nodules that cannot be accessed by percutaneous transthoracic needle biopsy.MethodsIn this single-center retrospective study, we reviewed patients who underwent ENB for high-risk pulmonary nodules. All procedures were performed under moderate sedation using intravenous midazolam and fentanyl.ResultsA total of 100 pulmonary nodules in 90 patients were subjected to ENB between October 2018 and May 2020. The median age of the study population was 66 (59-73). The mean diameter of the lung nodules was 27.9 mm. The diagnostic yield of ENB-guided biopsy was 53.0%. Although the nodule size (odds ratio: 1.055, p = 0.007) and positive bronchus sign (odds ratio: 2.918, p = 0.020) were associated with the diagnostic yield during univariate analysis, nodule size was the only independent variable on the multivariable analysis. Interestingly, the diagnostic yield showed an upward trend after 60 cases, from 45%-65%. Procedure-related complications were reported in 16 cases; among these, pneumothorax occurred in three cases, and four cases experienced moderate bleeding. No instance of major bleeding or death was linked to ENB-guided biopsy.ConclusionENB-guided biopsy for high-risk pulmonary nodules demonstrated an acceptable diagnostic yield and good safety profile. Moreover, the diagnostic yield was associated with nodule size and procedure experience.
| S-EPMC8107026 | biostudies-literature
Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) has been widely adopted as a guidance technique for biopsy of peripheral lung nodules. However, ENB is limited by the lack of real-time confirmation of the biopsy devices. Intraprocedural cone-beam computed tomography (CBCT) imaging can be utilized to assess or confirm the location of biopsy devices. The aim of this study is to determine the safety and diagnostic yield (DY) of image fusion of intraprocedural CBCT data with live fluoroscopy (augmented fluoroscopy) during ENB-guided biopsy of peripheral lung nodules.MethodsData from 75 consecutive patients who underwent biopsy with ENB was collected retrospectively. Patients underwent CBCT imaging while temporarily suspending mechanical ventilation. CBCT data were acquired and 3-dimensional segmentation of nodules was performed using commercially available software (OncoSuite). During ENB, the segmented lesions were projected and fused with live fluoroscopy enabling real-time 3-dimensional guidance.ResultsA total of 93 lesions with a median size of 16.0 mm were biopsied in 75 consecutive patients. The overall DY by lesion was 83.7% (95% confidence interval, 74.8%-89.9%). Multivariate regression analysis showed no independent correlation between lesion size, lesion location, lesion visibility under standard fluoroscopy, and the presence of a bronchus sign with DY. Pneumothorax occurred in 3 patients (4%).ConclusionIntraprocedural CBCT imaging with augmented fluoroscopy is feasible and effective and is associated with high DY during ENB-guided biopsies.
| S-EPMC6166698 | biostudies-literature
Project description:BackgroundMicrowave ablation of lung nodules may provide a faster, larger and more predictable ablation zone than other energy sources, while bronchoscopic transbronchial ablation has theoretical advantage of fewer pleural-based complications than percutaneous approach. Our study aims to determine whether the novel combination of bronchoscopic approach and microwave ablation in management of lung nodules is technically feasible, safe and effective.MethodsThis is a retrospective analysis of a single center experience in electromagnetic navigation bronchoscopy microwave ablation in hybrid operating room. Patients had high surgical risks while lung nodules were either proven malignant or radiologically suspicious. Primary endpoints include technical feasibility and safety.ResultsTotal of 30 lung nodules from 25 patients were treated. Mean nodule size was 15.1 mm, and bronchus directly leads to the nodules (bronchus sign positive) in only half of them. Technical success rate was 100%, although some nodules required double ablation for adequate coverage. Mean minimal ablation margin was 5.51 mm. The mean actual ablation zone volume was -21.4% compared to predicted, likely due to significant tissue contraction ranging from 0-43%. There was no significant heat sink effect. Mean hospital stay was 1.73 days, and only 1 patient stayed for more than 3 days. Complications included pain (13.3%), pneumothorax requiring drainage (6.67%), post-ablation reaction (6.67%), pleural effusion (3.33%) and hemoptysis (3.33%). After median follow up of 12 months, none of the nodules had evidence of progression.ConclusionsBronchoscopic transbronchial microwave ablation is safe and feasible for treatment of malignant lung nodules. Prospective study on clinical application of this novel technique is warranted.
| S-EPMC8107744 | biostudies-literature
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:BackgroundElectromagnetic navigation bronchoscopy (ENB) is an emerging advanced imaging-guided bronchoscopy technique for diagnosing peripheral lung lesions. However, the selection strategy for the optimal biopsy device and whether adopting a multi-tool strategy increases the diagnostic yield remains undetermined. The CONFIDENT-ENB trial (NCT05110131) is a prospective randomized study on ENB, performed in a least-invasive setting. The primary aim is to evaluate whether a combination of needle aspiration and forceps biopsy improves the diagnostic performance, and assess the comparative diagnostic value and discordance of the two devices.MethodsThe trial will recruit 142 participants with lung lesions suspected of malignancy who are eligible for an elective ENB procedure under moderate sedation. Participants will undergo ENB-guided needle aspiration and forceps biopsy in a randomized order without the use of any complementary techniques. All participants will be followed up subsequently for up to 12 months to conclude the final diagnosis of the biopsied lesions. Primary outcomes include the diagnostic yield and sensitivity of each biopsy modality and the diagnostic yield of the combined modalities.DiscussionThe CONFIDENT-ENB trial will prospectively evaluate the synergistic effectiveness and comparative accuracy of ENB-guided needle aspiration and forceps biopsy in a least-invasive setting. The results are expected to improve our understanding of the optimal tool-selection strategy for ENB.Trial registrationClinicalTrials.gov (NCT05110131). Prospectively registered on 5 November 2021.
| S-EPMC9392264 | 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:CT-body divergence limits the accuracy of electromagnetic navigation bronchoscopy(ENB) in peripheral lung lesions diagnosis. Finding one effective and safe method to eliminating CT-body divergence may improve ENB accuracy. Thus, we developed a modified ENB which combining intraprocedural CT guided Navigation with Ventilatory strategy for Atelectasis to eliminate CT-body divergence. We called it inCTNVA-ENB. We present the case of an 80-year-old female with peripheral pulmonary nodule (without bronchial direct connection). She underwent inCTNVA-ENB, and the navigation probe accurately reached 6mm next to the target lesion without complications. The operation time was 42 minutes, and rapid on-site evaluation showed adenocarcinoma cells. CT data revealed the CT-body divergence caused by atelectasis was reduced.
| S-EPMC11472628 | 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