Electromagnetic navigation bronchoscopy fiducial marker margin identification plus triple dye for complete lung nodule resection.
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ABSTRACT:
SUBMITTER: Chan JWY
PROVIDER: S-EPMC8304901 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:It is a great challenge for surgeons to resect pulmonary nodules with small volume, deep position and no solid components under video-assisted thoracoscopic surgery. The purpose of this study is to explore the feasibility and necessity of the localization of pulmonary nodules by injecting indocyanine green (ICG) under the guidance of magnetic navigation bronchoscope and the resection of small pulmonary nodules under the fluoroscope. METHODS:Between December 2018 and August 2019, sixteen consecutive patients with 30 peripheral lung lesions in our hospital received fluorescent thoracoscopic pulmonary nodule resection. Electromagnetic navigation bronchoscope (ENB) was performed before surgery to guide ICG to the target lesion. RESULTS:All patients underwent magnetic navigation-guided pulmonary nodule localization, and surgical resection was performed immediately after localization was completed. The average size of the nodules was (11.12±3.65) mm. The average navigation time was (12.06±2.74) minutes, and the average interval between dye labeling and lung resection was (25.00±5.29) minutes. All lesions were completely resected, the localization success rate was 100.00%, no bleeding and other complications occurred after the localization, the postoperative pathological results confirmed the accuracy of the staining. CONCLUSIONS:Indocyanine green injection under the guidance of magnetic navigation bronchoscope is an effective way to locate pulmonary nodules, which can locate small and untouchable lesions in the lung. This method can help surgeons identify lesions more quickly and accurately. It is practical and worthy of promotion.
| S-EPMC7309554 | biostudies-literature
Project description:BACKGROUND:Fiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB). METHODS:NAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24?months is ongoing. RESULTS:Two-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0?min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 ± 1.7 FMs (median 1.0?FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade???2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade ? 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages. CONCLUSION:ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02410837.
| S-EPMC6454637 | 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:Electromagnetic 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.NAVIGATE (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.Study 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.ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
| S-EPMC4845335 | 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: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:Thoracoscopic resection of small subsolid nodules is challenging and requires preoperative localization. We investigated the efficacy, safety, and factors affecting accuracy in localizing pulmonary nodules with electromagnetic navigation bronchoscopy (ENB)-guided dye marking.Patients with small subsolid nodule(s) who underwent thoracoscopic resection after ENB-guided dye marking were retrospectively reviewed. Dye marking was performed at the nearest pleura and the localized nodule(s) was resected thoracoscopically. Efficacy was evaluated by success rates of dye marking and resection of nodules. Navigation accuracy was represented by target distance, which was the closest distance between target and the tip of locatable guide. Factors affecting target distance were evaluated by linear regression analyses.Twenty-nine ENB-guided dye markings were done for 24 nodules in 20 patients. The success rate of the dye marking and nodule localization were 93.1% (27/29) and 95.8% (23/24), respectively. Twenty-three nodules were completely resected thoracoscopically without conversion. There were no ENB-related complications: pneumothorax or bronchopulmonary hemorrhage. Nine targets were in the upper, 14 in the middle, and 6 in the lower zone. Even though navigation time was longer in the upper zone, target distance showed no significant inter-zone difference. Approach angle was the only significant predictor for target distance (0-45°, estimate = -1.24, P = .01; 45-90°, estimate = -1.26, P = .006; reference = ≥90°).Localization with ENB-guided dye marking is effective and safe for thoracoscopic resection of small subsolid nodules. For better performance, a pathway with smaller approach angle (<90°) should be selected to increase the navigation accuracy.
| S-EPMC6426580 | 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:Navigation bronchoscopy has reached a new horizon in its evolution. Combining with real-time imaging modalities, such as cone-beam computed tomography (CBCT) and augmented fluoroscopy (AF), navigation success can finally be confirmed with high degree of accuracy in real-time. With utilization of this modality, additional clinical observations are being made to help address the CT-body divergence problem and further improve navigation accuracy. This review focuses on description of CBCT navigation technique, provide tips on addressing CT-Body divergence, and review evidence for CBCT applications in navigation bronchoscopy.
| S-EPMC7330771 | 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