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. 2019 Jul 4;20(1):400.
doi: 10.1186/s13063-019-3532-z.

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial

Yin-Kai Chao  1 , Kuang-Tse Pan  2 , Chih-Tsung Wen  3 , Hsin-Yueh Fang  3 , Ming-Ju Hsieh  3
Affiliations

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial

Yin-Kai Chao et al. Trials. .

Abstract

Background: Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is concerned, the most common workflow consists of preoperative computed tomography (POCT) imaging-guided tumor marking (performed in an interventional CT suite) followed by their removal in an operating room (OR). However, the advent of hybrid ORs has allowed intraoperative computed tomography (IOCT)-guided lesion localization. This single center, open-label, randomized, controlled clinical trial aims to compare the efficacy and safety of IOCT versus POCT.

Methods/design: The study sample will consist of patients presenting with small and/or deep pulmonary nodules who will be randomly allocated to either POCT or IOCT. The time required to complete lesion localization will be the primary efficacy outcome. The following parameters will serve as secondary endpoints: rate of successful targeting during localization and in the operating field, time at risk, operating time, length of time under anesthesia, global OR utilization time, complication (pneumothorax and hemorrhage) rates, and radiation exposure.

Discussion: Owing to the increased availability of HORs, our data will be crucial to clarify the feasibility and safety of IOCT versus the traditional POCT approach.

Trial registration: ClinicalTrials.gov, NCT03395964 . Registered on October 8, 2018.

Keywords: ARTIS zeego; Hybrid operating room; Localization; Slitary pulmonary nodules.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the study
Fig. 2
Fig. 2
a Interventional radiology suite equipped with a 16-slice CT scanner (GE BrightSpeed; GE Healthcare, Milwaukee, WI, USA). b PBV dye injection following needle localization
Fig. 3
Fig. 3
a Hybrid operating room equipped with a cone-beam CT apparatus (ARTIS zeego; Siemens Healthcare GmbH, Erlangen, Germany) and a Magnus surgical table (Maquet Medical Systems, Wayne, NJ, USA). b The needle entry point and angulation were visualized by projecting a laser-targeting cross onto the patient’s surface
Fig. 4
Fig. 4
Schedule of patient enrolment, interventions, and assessments; Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
See this image and copyright information in PMC

References

    1. Team NLSTR Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;2011(365):395–409. - PMC - PubMed
    1. Suzuki K, Nagai K, Yoshida J, et al. Video-assisted thoracoscopic surgery for small indeterminate pulmonary nodules. Chest. 1999;115(2):563–568. doi: 10.1378/chest.115.2.563. - DOI - PubMed
    1. Finley RJ, Mayo JR, Grant K, et al. Preoperative computed tomography–guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015;149(1):26–32. doi: 10.1016/j.jtcvs.2014.08.055. - DOI - PubMed
    1. Detterbeck FC, Homer RJ. Approach to the ground-glass nodule. Clin Chest Med. 2011;32(4):799–810. doi: 10.1016/j.ccm.2011.08.002. - DOI - PubMed
    1. Lin M-W, Tseng Y-H, Lee Y-F, et al. Computed tomography-guided patent blue vital dye localization of pulmonary nodules in uniportal thoracoscopy. J Thorac Cardiovasc Surg. 2016;152(2):535–544. doi: 10.1016/j.jtcvs.2016.04.052. - DOI - PubMed

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