Robotic Surgery in Pulmonary Metastasectomy
NCT Number: NCT06466070
Acronym: ROME
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Primary Solid Tumors
Sponsor: Scientific Institute San Raffaele
Collaborators: Istituto Europeo di Oncologia|Istituto Clinico Humanitas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1650
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-11
Completion Date: 2026-12-31
Locations: IFO - Istituto Nazionale Tumori Regina Elena di Roma, Rome, Italy / Rome, 00128, Italy|Istituto Europeo di Oncologia, Milan, Italy/Milan, 20121, Italy|Istituto Clinico Humanitas, Rozzano, Italy/Milan, 20089, Italy

Summary:
The study is observational, multicenter retrospective and will involve multiple research centers. The aim is to outline the indications for surgical management with robot-assisted pulmonary metastasectomy through a confrontation of robot-assisted thoracoscopic surgery (RATS) with video-assisted thoracoscopic surgery (VATS) and thoracotomy. The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). There are no risks for the patients, as this is a retrospective data collection.

Primary Outcome Measures: PERIOPERATIVE OUTCOME, The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy.

The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing intra- and post-operative complications, which will be categorized according to Clavien-Dindo scale., from hospitalization to the discharge date at maximum one week|PERIOPERATIVE OUTCOME 2, The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy.

The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing the rate of resection radicality., from surgery to time of pathological response
Secondary Outcome Measures: PATHOLOGICAL OUTCOME, The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the number of cases which underwent radical lymphnode dissection or lymphnode sampling., from surgery to time of pathological response|PATHOLOGICAL OUTCOME 2, The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the number of resected hilar and mediastinal lymphnodes., from surgery to time of pathological response|PATHOLOGICAL OUTCOME 3, The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the frequency of positive lymphnodes., from surgery to time of pathological response|PATHOLOGICAL OUTCOME 4, The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the frequency of unexpected positive lymphnodes., from surgery to time of pathological response
Other Outcome Measures: ONCOLOGICAL LONG TERM OUTCOME, The investigators will evaluate the potential oncological benefit of Robotic Assisted Thoracic Surgery (RATS) by analizing Overall Survival (OS) of patients subjected to robotic resections, compared to Video Assisted Thoracoscopic Surgery (VATS) and open groups., From the discharge date to the follow up at 1year; 3 years and 5 years|ONCOLOGICAL LONG TERM OUTCOME 1, The investigators will evaluate the potential oncological benefit of Robotic Assisted Thoracic Surgery (RATS) by analizing Disease-Free Interval (DFI) of patients subjected to robotic resections, compared to Video Assisted Thoracoscopic Surgery (VATS) and open groups., From the discharge date to the follow up at 1year; 3 years and 5 years