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Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study.

ABSTRACT: 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.

SUBMITTER: Chen KC

PROVIDER: S-EPMC5911748 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study.

Chen Ke-Cheng KC Lee Jang-Ming JM

Journal of thoracic disease 20180401 Suppl 6

<h4>Background</h4>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.<h4>Methods</h4>Our study includes patients with primary or metasta ...[more]

PMID: 29732193

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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.

Dataset Information

Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study.

Publications

Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study.

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