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X. Zheng



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    P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P2.04-011 - The Using of LungCare Electromagnetic Navigated Bronchoscopy System in Lung Lesions, a New Project in China (ID 8787)

      09:30 - 16:00  |  Author(s): X. Zheng

      • Abstract

      Background:
      With the application of low dose computed tomography in screening lung cancer for high-risk population, more peripheral pulmonary lesions are found which need to be diagnosed or treated. Traditional methods include transthoracic needle aspiration (TTNA) or transbronchial lung biopsy (TBLB) are not recommended nowadays because of its low diagnostic rate, more complications and high radiation dose for patients. Moreover, they lack real-time navigation system for guiding bronchoscope to the distal lesion where traditional methods hardly reach and highly depends on operators with knowledge of CT scans. Electromagnetic navigated bronchoscopy (ENB) has proven to be a novel technology, including electromagnetic tracking, virtual bronchoscopic navigation and CT reconstruction technologies. Only two commercial ENB systems have been approved by FDA in the United States. And more than 1,000 medical institutions have been equipped with ENB in Europe and the United States. As of the end of June 2016, more than 10 imported ENB systems were installed in China.

      Method:
      This project has been supported by the ministry of science and technology of the People’s Republic of China in 2017(2017YFC0112700). This project will utilize the domestic LungCare ENB system and its improved version to carry out five innovative sub-projects. These projects will cover all the issues of ENB on the early peripheral lung cancers (Stage IA), including the diagnosis, localization and treatment.

      Result:
      First, the project will utilize the CFDA approved LungCare ENB system to perform a large, prospective, multicenter, randomized study, which aims to enroll up to total 1362 consecutive subjects presenting for evaluation (diagnosis, localization and treatment) of lung lesions utilizing the ENB procedure at up to 3 clinical sites. Second, LungCare ENB system will upgrade their products and develop two new navigation systems including the transthoracic electromagnetic navigation system(TTEN) and the video assisted thoracoscopic surgery electromagnetic navigation system (VATS-EN). Two clinical studies will be performed in 3 clinical sites individually.

      Conclusion:
      LungCare ENB total solution including ENB, TTEN and VATS-EN, will extend their electromagnetic navigation system of the single use from the bronchus to the thoracic wall, and even through the thoracoscope. The value of the project will form the whole-lung electromagnetic navigation system and focus on the accurate diagnose, localization and treatment of early peripheral lung cancer.