Proof of concept: Shape-sensing robotic-assisted bronchoscopy performed under moderate sedation.
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ABSTRACT:
SUBMITTER: Donna E
PROVIDER: S-EPMC9763841 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
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Proof of concept: Shape-sensing robotic-assisted bronchoscopy performed under moderate sedation.
Donna Elio E Wu Steven S Arias Sixto S
Respiratory medicine case reports 20221201
We describe a first reported case of shape-sensing robotic-assisted bronchoscopy using ION-intuitive platform done successfully under moderate sedation. A 76-year-old woman was found to have a right upper lobe mass measuring 3 × 2.9 cm. Diagnostic robotic navigational bronchoscopy was successfully performed under moderate sedation. Pathologic examination later revealed adenocarcinoma consistent with primary pulmonary malignancy. Conscious sedation allows the use of robotic bronchoscopy with mini ...[more]
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Project description:BackgroundThe landscape of guided bronchoscopy for the sampling of pulmonary parenchymal lesions is evolving rapidly. Shape-sensing robotic-assisted bronchoscopy (ssRAB) recently was introduced as means to allow successful sampling of traditionally challenging lesions.Research questionWhat are the feasibility, diagnostic yield, determinants of diagnostic sampling, and safety of ssRAB in patients with pulmonary lesions?Study design and methodsData from 131 consecutive ssRAB procedures performed at a US-based cancer center between October 2019 and July 2020 were captured prospectively and analyzed retrospectively. Definitions of diagnostic procedures were based on prior standards. Associations of procedure- and lesion-related factors with diagnostic yield were examined by univariate and multivariate generalized linear mixed models.ResultsA total of 159 pulmonary lesions were targeted during 131 ssRAB procedures. The median lesion size was 1.8 cm, 59.1% of lesions were in the upper lobe, and 66.7% of lesions were beyond a sixth-generation airway. The navigational success rate was 98.7%. The overall diagnostic yield was 81.7%. Lesion size of ≥ 1.8 cm and central location were associated significantly with a diagnostic procedure in the univariate analysis. In the multivariate model, lesions of ≥ 1.8 cm were more likely to be diagnostic compared with lesions < 1.8 cm, after adjusting for lung centrality (OR, 12.22; 95% CI, 1.66-90.10). The sensitivity and negative predictive value of ssRAB for primary thoracic malignancies were 79.8% and 72.4%, respectively. The overall complication rate was 3.0%, and the pneumothorax rate was 1.5%.InterpretationThis study was the first to provide comprehensive evidence regarding the usefulness and diagnostic yield of ssRAB in the sampling of pulmonary parenchymal lesions. ssRAB may represent a significant advancement in the ability to access and sample successfully traditionally challenging pulmonary lesions via the bronchoscopic approach, while maintaining a superb safety profile. Lesion size seems to remain the major predictor of a diagnostic procedure.
| S-EPMC8941601 | biostudies-literature
Project description:BackgroundTraditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists' initial experience?MethodsThe lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median/interquartile range (IQR).ResultsSixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were < 18 mm with a largest cardinal diameter of 20.0 mm. Most nodules were extraluminal and distance from the outer edge of the nodule to the pleura or nearest fissure was 4.0 mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 66.5 min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of the virtual nodule was 7.0 mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported.ConclusionsBronchoscopists leveraged the Ion SSRAB's functionality to drive the catheter safely in close proximity of the virtual target and to obtain biopsies. This initial, multicenter experience is encouraging, suggesting that SSRAB may play a role in the management of pulmonary nodules. Clinical Trial Registration identifier and date NCT03893539; 28/03/2019.
| S-EPMC8520632 | biostudies-literature
Project description:BackgroundShape sensing robotic-assisted bronchoscopy (ssRAB) combined with radial endobronchial ultrasound (r-EBUS) and cone beam computed tomography (CBCT) is a newer diagnostic modality for the evaluation of pulmonary lesions. There is limited data describing the radiation dose of CBCT combined with ssRAB. The purpose of this study was to describe the technical factors associated with the use of CBCT combined with ssRAB to biopsy pulmonary lesions.MethodsWe conducted a single center, prospective observational study of patients undergoing ssRAB combined with fixed CBCT for the pulmonary lesion biopsy. We report our patient demographics, and pulmonary lesion and procedure characteristics.ResultsA total of 241 ssRAB procedures were performed to biopsy 269 pulmonary lesions. The mean lesion size was measured in the following dimensions: anteroposterior (18.0±8.8 mm), transverse (17.2±10.5 mm), and craniocaudal (17.7±10.2 mm). A mean of 1.5±0.7 (median: 1, range: 1-4) CBCT spins were performed. The mean total fluoroscopy time (FT) was 5.6±2.9 minutes. The mean radiation dose of cumulative air kerma (CAK) was 63.5±46.7 mGy and the mean cumulative dose area product (DAP) was 22.6±16.0 Gy·cm2. Diagnostic yield calculated based on results at index bronchoscopy was 85.9%. There was a low rate of complications with 8 pneumothoraces (3.3%), 5 (2.1%) of which required chest tube placement.ConclusionsWe describe the use of ssRAB combined with CBCT to biopsy pulmonary lesions as a safe diagnostic modality with relatively low radiation dose that is potentially comparable to other image guided sampling modalities. Bronchoscopists should be cognizant of the radiation use during the procedure for both patient and staff safety.
| S-EPMC10586938 | biostudies-literature
Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) and shape-sensing robotic-assisted bronchoscopy (ssRAB) are minimally invasive technologies for the diagnosis of pulmonary nodules. Cone-beam computed tomography (CBCT) has shown to increase diagnostic yield by allowing real-time confirmation of position of lesion and biopsy tool. There is a lack of comparative studies of such platforms using CBCT guidance to overcome computed tomography to body divergence. The aim of this study was to compare the diagnostic yield of ENB- and ssRAB-guided CBCT for biopsy of pulmonary nodules.MethodsWe conducted a retrospective comparative study of consecutive patients undergoing ENB-CBCT and ssRAB-CBCT. Navigational success was defined as biopsy tool within lesion confirmed during CBCT. Diagnostic yield was assessed using two methods: (I) presence of malignancy or benign histological findings that lead to a specific diagnosis at the time of bronchoscopy, and (II) longitudinal follow-up of patients with nonspecific benign finding during bronchoscopy.ResultsENB-CBCT was used to biopsy 97 nodules and ssRAB-CBCT was used to biopsy 111 nodules. Median size of the lesion for the ENB-CBCT group was 16.5 mm [interquartile range (IQR), 12-22 mm] as compared to 12 mm (IQR, 9-16 mm) in the ssRAB-CBCT group (P<0.001). Navigational success was 70.1% in ENB-CBCT arm as compared to 83% in ssRAB-CBCT arm respectively (P=0.03). Diagnostic yield was 66% for ENB-CBCT and 89.2% for ssRAB-CBCT (P<0.001) following bronchoscopy; 79.4% for ENB-CBCT and 95.4% for ssRAB-CBCT (P<0.001) with longitudinal follow-up data respectively. Following multivariate regression analysis adjusting for the size of the lesion, distance from the pleura, presence of bronchus sign, number of CBCT spins, and number of nodules, the odds ratio for the diagnostic yield was 4.72 [95% confidence interval (CI): 2.05-10.85; P<0.001] in the ssRAB-CBCT group as compared with ENB-CBCT. The overall rate of adverse events was similar in both groups (P=0.77).ConclusionsssRAB-CBCT showed increased navigational success and diagnostic yield as compared to ENB-CBCT for pulmonary nodule biopsies.
| S-EPMC11494579 | biostudies-literature
Project description:Background and objectiveRobotic-assisted bronchoscopy (RAB) has emerged as an advanced technology for lung cancer diagnosis. This review explores the three approved robotic bronchoscopy systems: Ion™ Endoluminal (Intuitive Surgical, Sunnyvale, CA, USA), Monarch™ (Johnson & Johnson, Redwood City, CA, USA), and Galaxy System™ (Noah Medical, San Carlos, CA, USA), and their different operational systems. This narrative review aims to summarize their findings and outcomes for sampling peripheral pulmonary lesions (PPL) suspected of lung cancer.MethodsA search in PubMed and Google Scholar databases was conducted for articles and abstracts published between January 2018 to May 2024 using the terms "robotic bronchoscopy" or "robotic-assisted bronchoscopy" for biopsy of PPL.Key content and findingsLung cancer is the leading cause of cancer-related mortality. The introduction of RAB aims to improve the feasibility and safety of sampling PPL. Current literature describes high diagnostic yields with low risk of complications, allowing concurrent hilar and mediastinal staging within the same procedure. RAB can potentially improve early diagnosis and treatment of pulmonary malignancies and survival rate in long term, while progressing towards therapeutic applications in the near future.ConclusionsAs RAB evolves, its potential as a "one-stop shop" for diagnosis, staging, and treatment can positively impact lung cancer detection, focusing on improved patient-centered outcomes and reducing multiple diagnostic and therapeutic procedures.
| S-EPMC11388208 | biostudies-literature
Project description:IntroductionUreteroscopy (URS) is commonly performed under general anesthesia (GA) to maximize patient tolerability and minimize surgical complications; however, given the improvements in endoscopic technology and risks associated with GA, alternate forms of anesthesia have been postulated. We aimed to evaluate the outcomes of URS under conscious sedation.MethodsWe completed a retrospective cohort study from November 2019 to June 2020 at a tertiary-level hospital. All URSs that were performed under urologist-directed conscious sedation were included. Our primary outcome was the ability to complete URS, defined as success rate. Secondary outcomes included: stone-free rate, intraoperative complication rate, hospital admission rate, and sedation requirement. Univariate- and multivariate-adjusted logistic regression analyses were employed.ResultsNinety-nine URSs were included. Most (73/99, 73.7%) were performed for urolithiasis. The overall success rate was 83.8% (83/99), with 81.0% (34/42) intra-renal and 70.0% (16/23) proximal ureter success rates. The stone-free rate was 80.8% (59/73). No intraoperative complications nor hospital admissions were reported. The mean amount of sedation required was 3 mg (interquartile range [IQR] 2-4] of midazolam and 100 μg (100-150) of fentanyl. On multivariate analysis, midazolam was significantly associated with increased success (odds ratio 2.496, 95% confidence interval 1.057-5.892, p=0.037).ConclusionsWe have shown that proximal and intrarenal URS under conscious sedation is safe and effective. We were limited by our lack of followup, small sample size, selection bias to chose healthy patients, and lack of patient tolerability data. Patients and healthcare systems may benefit from implementing this innovation more broadly.
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Project description:In this paper, we present a novel on-demand modular robotic photoacoustic tomography (PAT) probe integrated into an endoscopic device, potentially for deep intragastric sensing. The proposed solution offers a plug-and-play approach through the use of meso-scale steerable endoscopy and a new 'snap-on' 3D robotic PAT probe that can reconfigure the geometry of the intracorporeal light delivery, inspired by an umbrella structure. Specifically, using the limited esophageal access, steerable endoscopy allows navigation and advancement of a distally mounted robotic add-on for PAT that is folded until it reaches the deep-seated gastric lesion. Once the tip is positioned near the lesion site in the gastric cavity, there is ample working space for the robotic probe to adjust its umbrella-like unfolded shape. This allows fine-tuning of the laser delivery orientation of the fiber bundles to achieve the lesion-specific light delivery scheme. This design allows volumetric imaging of the intragastric PAT with enhanced sensitivity. To evaluate the performance of the modular robotic PAT probe, we performed a simulation analysis of the light intensity and ultrasound field distribution. The simulation results show that the robotic probe is feasible for intracorporeal PAT imaging. In addition, we printed a 3D model of a human stomach containing a simulated gastric tumour. Both the phantom and ex vivo experimental results validate the feasibility of the proposed robotic PAT probe.
| S-EPMC10835348 | biostudies-literature
Project description:ObjectiveTo determine whether CT-to-body divergence can be overcome to improve the diagnostic yield of peripheral pulmonary nodules with the combination of shape-sensing robotic-assisted bronchoscopy (SSRAB) and portable 3-dimensional (3D) imaging.Patients and methodsA single-center, prospective, pilot study was conducted from February 9, 2021, to August 4, 2021, to evaluate the combined use of SSRAB and portable 3D imaging to visualize tool-in-lesion as a correlate to diagnostic yield.ResultsThirty lesions were subjected to biopsy in 17 men (56.7%) and 13 women (43.3%). The median lesion size was 17.5 mm (range, 10-30 mm), with the median airway generation of 7 and the median distance from pleura of 14.9 mm. Most lesions were in the upper lobes (18, 60.0%). Tool-in-lesion was visualized at the time of the procedure in 29 lesions (96.7%). On the basis of histopathologic review, 22 (73.3%) nodules were malignant and 6 (20.0%) were benign. Two (6.7%) specimens were suggestive of inflammation, and the patients elected observation. The mean number of spins was 2.5 (±1.6) with a mean fluoroscopy time of 8.7 min and a mean dose area product of 50.3 Gy cm2 (±32.0 Gy cm2). There were no episodes of bleeding or pneumothorax. The diagnostic yield was 93.3%.ConclusionThis pilot study shows that the combination of mobile 3D imaging and SSRAB of pulmonary nodules appears to be safe and feasible. In conjunction with appropriate anesthetic pathways, nodule motion and divergence can be overcome in most patients.Trial registrationhttps://clinicaltrials.gov Identifier NCT04740047.
| S-EPMC9059066 | biostudies-literature
Project description:BackgroundWithin surgery, assistive robotic devices (ARD) have reported improved patient outcomes. ARD can offer the surgical team a "third hand" to perform wider tasks and more degrees of motion in comparison with conventional laparoscopy. We test an eye-tracking based robotic scrub nurse (RSN) in a simulated operating room based on a novel real-time framework for theatre-wide 3D gaze localization in a mobile fashion.MethodsSurgeons performed segmental resection of pig colon and handsewn end-to-end anastomosis while wearing eye-tracking glasses (ETG) assisted by distributed RGB-D motion sensors. To select instruments, surgeons (ST) fixed their gaze on a screen, initiating the RSN to pick up and transfer the item. Comparison was made between the task with the assistance of a human scrub nurse (HSNt) versus the task with the assistance of robotic and human scrub nurse (R&HSNt). Task load (NASA-TLX), technology acceptance (Van der Laan's), metric data on performance and team communication were measured.ResultsOverall, 10 ST participated. NASA-TLX feedback for ST on HSNt vs R&HSNt usage revealed no significant difference in mental, physical or temporal demands and no change in task performance. ST reported significantly higher frustration score with R&HSNt. Van der Laan's scores showed positive usefulness and satisfaction scores in using the RSN. No significant difference in operating time was observed.ConclusionsWe report initial findings of our eye-tracking based RSN. This enables mobile, unrestricted hands-free human-robot interaction intra-operatively. Importantly, this platform is deemed non-inferior to HSNt and accepted by ST and HSN test users.
| S-EPMC8186017 | biostudies-literature
Project description:BackgroundIncidental and screen-detected pulmonary nodules are common. The increasing capabilities of advanced diagnostic bronchoscopy will increase bronchoscopists' procedural volume necessitating optimization of procedural scheduling and workflow.ObjectivesThe objectives of this study were to determine total time in the procedure room, total bronchoscopy procedure time, and robotic-assisted bronchoscopy procedure time longitudinally and per specific procedure performed.DesignA single-center observational study of all consecutive patients undergoing shape-sensing robotic-assisted bronchoscopy (RAB) biopsy procedures for the evaluation of pulmonary lesions with variable probability for malignancy.MethodsChart review to collect patient demographics, lesion characteristics, and procedural specifics. Descriptive and comparative statistics are reported.ResultsActual bronchoscopy procedure time may decrease with increased institutional experience over time, however, there is limited ability to reduce non-bronchoscopy related time within the procedure room. The use of cone beam computed tomography (CBCT), rapid on-site evaluation (ROSE), and performance of staging endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) in a single procedure are each associated with additional time requirements.ConclusionInstitutional procedural block times should adapt to the nature of advanced diagnostic bronchoscopy procedures to allow for the accommodation of new modalities such as RAB combined with other technologies including radial endobronchial ultrasound, CBCT, ROSE, and staging linear EBUS. Identifying institutional median procedural times may assist in scheduling and ideal block time utilization.
| S-EPMC11378166 | biostudies-literature