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Goal: We present a new framework for in vivo image guidance evaluation and provide a case study on robotic partial nephrectomy. Methods: This framework (called the "bystander protocol") involves two surgeons, one who solely performs the therapeutic process without image guidance, and another who solely periodically collects data to evaluate image guidance. This isolates the evaluation from the therapy, so that in-development image guidance systems can be tested without risk of negatively impacting the standard of care. We provide a case study applying this protocol in clinical cases during robotic partial nephrectomy surgery. Results: The bystander protocol was performed successfully in 6 patient cases. We find average lesion centroid localization error with our IGS system to be 6.5 mm in vivo compared to our prior result of 3.0 mm in phantoms. Conclusions: The bystander protocol is a safe, effective method for testing in-development image guidance systems in human subjects.
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Introduction: Three-dimensional image-guided surgical (3D-IGS) systems for minimally invasive partial nephrectomy (MIPN) can potentially improve the efficiency and accuracy of intraoperative anatomical localization and tumor resection. This review seeks to analyze the current state of research regarding 3D-IGS, including the evaluation of clinical outcomes, system functionality, and qualitative insights regarding 3D-IGS's impact on surgical procedures. Methods: We have systematically reviewed the clinical literature pertaining to 3D-IGS deployed for MIPN. For inclusion, studies must produce a patient-specific 3D anatomical model from two-dimensional imaging. Data extracted from the studies include clinical results, registration (alignment of the 3D model to the surgical scene) method used, limitations, and data types reported. A subset of studies was qualitatively analyzed through an inductive coding approach to identify major themes and subthemes across the studies. Results: Twenty-five studies were included in the review. Eight (32%) studies reported clinical results that point to 3D-IGS improving multiple surgical outcomes. Manual registration was the most utilized (48%). Soft tissue deformation was the most cited limitation among the included studies. Many studies reported qualitative statements regarding surgeon accuracy improvement, but quantitative surgeon accuracy data were not reported. During the qualitative analysis, six major themes emerged across the nine applicable studies. They are as follows: 3D-IGS is necessary, 3D-IGS improved surgical outcomes, researcher/surgeon confidence in 3D-IGS system, enhanced surgeon ability/accuracy, anatomical explanation for qualitative assessment, and claims without data or reference to support. Conclusions: Currently, clinical outcomes are the main source of quantitative data available to point to 3D-IGS's efficacy. However, the literature qualitatively suggests the benefit of accurate 3D-IGS for robotic partial nephrectomy.
