Format

Send to

Choose Destination
J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.

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

Author information

1
Department of Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
2
Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
3
Siemens Corporation, Corporate Technology, Princeton, New Jersey.
4
Department of Anaesthesia, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
5
Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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

PMID:
26031893
PMCID:
PMC4539147
DOI:
10.1002/jso.23941
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center