Clinical Trial Protocol For reprint orders, please contact: reprints@futuremedicine.com VATS-US1: Thoracoscopic ultrasonography for the identifcation of nodules during lung metastasectomy Francesco Londero 1 , Luigi Castriotta 2 , William Grossi 1 , Gianluca Masullo 1 , Angelo Morelli 1 , Cecilia Tetta 3 , Ugolino Livi 1 , Jos G Maessen 4 & Sandro Gelsomino* ,4 1 Department of Cardiothoracic Surgery, S Maria della Misericordia University Hospital, Udine, Italy 2 Department of Clinical Epidemiology, S Maria della Misericordia University Hospital, Udine, Italy 3 Radiology Department, Rizzoli Institute, Bologna, Italy 4 Cardiothoracic Department, Maastricht University Hospital, Maastricht, The Netherlands *Author for correspondence: sandro.gelsomino@maastrichtuniversity.nl Open thoracotomy during pulmonary metastasectomy allows lung palpation and may discover unex- pected further nodules. We assess the validity of intraoperative lung ultrasonography via thoracoscopy in identifying lung nodules. A frst surgeon will perform an ultrasonographic investigation on the de- fated lung by thoracoscopy. A second surgeon will then perform a manual exploration of the organ by thoracotomy. Data on number and localization of nodules will be matched and compared with fnal his- tology report. Sensitivity and specifcity will be assessed. Concordance will be assessed with Cohen K test. Calculated sample size is 89 patients. This study might have an important role in shifting the surgical prac- tice towards a less invasive approach, with consequent benefts for the patient. Protocol is registered on clinicaltrials.gov. Protocol registration number: NCT03864874. First draft submitted: 27 September 2019; Accepted for publication: 29 November 2019; Published online: 9 January 2020 Keywords: lung metastases • ultrasound • VATS Pulmonary metastasectomy is a surgical practice that poses many aspects of debate: standard approach has historically been represented by open thoracotomy [1], but video-assisted thoracic surgery (VATS) became an appealing alternative due to the lower surgical impact on the patient. Some authors blame the minimally invasive approach for pulmonary metastasectomy as less effective from an oncologic point of view since lung palpation is hampered, leading to reduced ability to identify unexpected nodules and potential impairment of surgical radicality [2–4]. Indeed, several papers demonstrated a suboptimal sensitivity of computed tomography (CT) and positron- emission tomography in detecting lung metastases [2,4] and discovery of further unexpected nodules at thoracotomy are not an uncommon eventuality [3]. A few authors demonstrated the utility of intraoperative lung ultrasound performed through a VATS approach (VATS-US) in identifying lung nodules [5–7]. However, the real effectiveness of this technique has never been prospectively compared with the current gold standard represented by open thoracotomy and lung manual ex- ploration. Aim of our study is to assess the noninferiority of VATS-ultrasonography (US) compared with manual palpation to identify lung nodules during pulmonary metastasectomy. Materials & methods The study was approved by the local ethics committee of Friuli-Venezia-Giulia, Italy (Protocol n 30948, 11 September 2018). Aim, design & setting The study design is a monocentric noninferiority diagnostic crossover trial, based on the execution of VATS-US in patients undergoing pulmonary metastasectomy with radical intent. Aim of the study is to assess the noninferiority Future Oncol. (2020) 16(5), 85–89 ISSN 1479-6694 85 10.2217/fon-2019-0608 C  2020 Future Medicine Ltd