Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial

Ritu R Gill, Yifan Zheng, Julianne S Barlow, Jagadeesan Jayender, Erin E Girard, Philip M Hartigan, Lucian R Chirieac, Carol J Belle-King, Kristen Murray, Christopher Sears, Jon O Wee, Michael T Jaklitsch, Yolonda L Colson, Raphael Bueno, Ritu R Gill, Yifan Zheng, Julianne S Barlow, Jagadeesan Jayender, Erin E Girard, Philip M Hartigan, Lucian R Chirieac, Carol J Belle-King, Kristen Murray, Christopher Sears, Jon O Wee, Michael T Jaklitsch, Yolonda L Colson, Raphael Bueno

Abstract

Purpose: To facilitate localization and resection of small lung nodules, we developed a prospective clinical trial (ClinicalTrials.gov number NCT01847209) for a novel surgical approach which combines placement of fiducials using intra-operative C-arm computed tomography (CT) guidance with standard thoracoscopic resection technique using image-guided video-assisted thoracoscopic surgery (iVATS).

Methods: Pretrial training was performed in a porcine model using C-arm CT and needle guidance software. Methodology and workflow for iVATS was developed, and a multi-modality team was trained. A prospective phase I-II clinical trial was initiated with the goal of recruiting eligible patients with small peripheral pulmonary nodules. Intra-operative C-arm CT scan was utilized for guidance of percutaneous marking with two T-bars (Kimberly-Clark, Roswell, GA) followed by VATS resection of the tumor.

Results: Twenty-five patients were enrolled; 23 underwent iVATS, one withdrew, and one lesion resolved. Size of lesions were: 0.6-1.8 cm, mean = 1.3 ± 0.38 cm.. All 23 patients underwent complete resection of their lesions. CT imaging of the resected specimens confirmed the removal of the T-bars and the nodule. Average and total procedure radiation dose was in the acceptable low range (median = 1501 μGy*m(2), range 665-16,326). There were no deaths, and all patients were discharged from the hospital (median length of stay = 4 days, range 2-12). Three patients had postoperative complications: one prolonged air-leak, one pneumonia, and one ileus.

Conclusions: A successful and safe step-wise process has been established for iVATS, combining intra-operative C-arm CT scanning and thoracoscopic surgery in a hybrid operating room.

Keywords: C-arm CT; VATS; advanced image guided operating room; fiducials; hybrid operating room; lung cancer.

© 2015 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
(a) Pre‐operative axial CT image depicting a 6mm solid right lower lobe nodule. (b) 3D volume rendered image showing the relationship of the nodule to the bones. (c) i‐Guide pathway planning on sagittal C‐arm CT image. (d) T‐bar (fiducial). (e) Placement of the fiducials under fluoroscopic guidance using i‐Guide. (f) Fluoroscopy image after deployment of the fiducials around the target. (g) Intra‐operative image showing the fiducial wires extending to the chest wall from the collapsed lung. (h) Resected lung specimen with both wires extending through the lung.
Figure 2
Figure 2
(a) Solid right upper lobe nodule in a patient with breast cancer and sarcoma, found to be consistent with a sarcoma metastasis. (b) Right lower lobe part solid nodule, on frozen section found to have micropapillary feature, prompting a decision for completion lobectomy. (c) Right upper lobe part solid lesion biopsy, was found to be consistent with lung cancer. (d) Right upper lobe part solid lesion with progressive growth, final pathology consistent with a granuloma. (e) Part solid lesion in the left lower lobe stable on two scans 3 months apart, but resolved on the day of the surgery.

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Source: PubMed

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