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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03925103
Recruitment Status Completed
First Posted April 23, 2019
Last update posted April 8, 2020
Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC). Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS. In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.
Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay. For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring. Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems. In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score. The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.
|Experimental: 3D VATS lobectomy
Patients undergo thoracoscopic lobectomy by a three-dimensional display system
Procedure: 3D VATS lobectomy
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
|Active Comparator: 2D VATS lobectomy
Patients undergo thoracoscopic lobectomy by a two-dimensional display system
Procedure: 2D VATS lobectomy
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
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- Clinical NSCLC early stage (stage I-II).
- Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon
- Both predicted postoperative (PPO) FEV1 and PPO DLCO >35%
- American Society of Anesthesia (ASA) score18 II
- History of Neoadjuvant chemotherapy or radiotherapy
- Radiologic evidence of extensive pleural adhesions.
- Age 80 years.
- Patients with previous pleurodesis or thoracotomy in the affected hemithorax.
- Patients who will undergo surgical lung resection other than lobectomy.
- Patients with severe comorbidity contraindicating lobectomy.
- Patients refusal or noncompliance to general surgery and one-lung ventilation.
Policlinico Tor Vergata University
University of Rome Tor Vergata
Principal Investigator: Eugenio Pompeo, MD Tor Vergata University
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Dong S, Yang XN, Zhong WZ, Nie Q, Liao RQ, Lin JT, Wu YL. Comparison of three-dimensional and two-dimensional visualization in video-assisted thoracoscopic lobectomy. Thorac Cancer. 2016 Sep;7(5):530-534. doi: 10.1111/1759-7714.12361. Epub 2016 May 23.
Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16. Review.