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Design of a prospective, multicenter, and cohort study of an innovative electromagnetic navigation bronchoscopy in diagnosing pulmonary nodules among Chinese population.

ABSTRACT: 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.

SUBMITTER: Xie F

PROVIDER: S-EPMC6988046 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Design of a prospective, multicenter, and cohort study of an innovative electromagnetic navigation bronchoscopy in diagnosing pulmonary nodules among Chinese population.

Xie Fangfang F Zhang Jian J Cao Liming L Zheng Xiaoxuan X Chen Junxiang J Li Ying Y Han Baohui B Sun Jiayuan J

Journal of thoracic disease 20191201 12

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 canc ...[more]

PMID: 32030279

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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.

Project description:Background: Electromagnetic navigational bronchoscopy (ENB) and robotic-assisted bronchoscopy (RB) require a high degree of decision-making and psychomotor skill. Cognitive load theory is the overall effort expended by individuals in response to a task and is closely related to the usability of devices for medical procedures. High cognitive workload leads to poor surgical outcomes and represents a bottleneck for learning that affects performance.Objective: To analyze the cognitive load associated with ENB and RB in experienced ENB practitioners learning RB.Methods: Six experienced ENB bronchoscopists performed ENB and RB on a human cadaver model of peripheral pulmonary nodules. To assess cognitive load, we used the Surgery Task Load Index (SURG-TLX) and biometric changes. The SURG-TLX questionnaire was given to the provider after every peripheral pulmonary nodule biopsy with ENB and RB. Pupillary dilation and screen changes were continuously measured throughout the procedure for each biopsy attempt to collect biometric measures of cognitive load. Procedural time and biopsy outcome were also recorded.Results: Forty procedures (ENB and RB) were analyzed. Task complexity (23%) and mental demand (21.4%) were the highest contributors to cognitive load in ENB and RB. The cumulative SURG-TLX was significantly lower for the RB (69.25 vs. 101.25; P < 0.01). Total procedure time was greater for ENB (6.7 min; SD 1.5) compared with RB (4.4 min; SD 1.5; P = 0.01). Pupillary diameter was similar across the modalities (RB vs. ENB), but the diameter was higher during the biopsy portion (4.25 mm) than the navigation portion (4.01 mm).Conclusion: The intrinsic cognitive load of RB was highly manageable by existing ENB practitioners, and in this study, RB appeared to be less mentally demanding. Future development and training should focus on task complexity and mental demand for RB. The biopsy portion, regardless of bronchoscopic modality, should be a focus for education and training.

Dataset Information

Design of a prospective, multicenter, and cohort study of an innovative electromagnetic navigation bronchoscopy in diagnosing pulmonary nodules among Chinese population.

Publications

Design of a prospective, multicenter, and cohort study of an innovative electromagnetic navigation bronchoscopy in diagnosing pulmonary nodules among Chinese population.

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