Robotic Surgery in Pulmonary Metastasectomy (ROME)

The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Solid Tumors

Detailed Description

The investigators will identify selection criteria according to ASA score (American Society of Anaesthesiologists physical status classification system ) and co-morbidities, respiratory function, control and staging of the primary pathology, number and position of metastases. The investigators will assess the robotic approach performance in the different anatomical resections (lobectomies, bilobectomies, segmentectomies,pneumectomies) considering potential intra- and post-operative complications, over than rates of positive margins.

It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), or with a traditional open approach. More precisely, it will compare RATS vs VATS as well as RATS vs open.

It was decided to exclude simple wedge resections since, in light of the minimal resection of parenchyma and the costs sustained for the equipment, they are preferably carried out by VATS.

Criteria for the inclusion of patients:

1. The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
2. The primary pathology is under control or controllable
3. Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion criteria:

• Age >/=; then 18 years at the moment of surgery
• Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

• Study Type: Observational
• Enrollment (Estimated): 1650

Contacts and Locations

Study Locations

• Italy
  • Italy / Rome
    • Rome, Italy / Rome, Italy, 00128
      • IFO - Istituto Nazionale Tumori Regina Elena di Roma
  • Italy/Milan
    • Milan, Italy/Milan, Italy, 20121
      • Istituto Europeo di Oncologia
    • Rozzano, Italy/Milan, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy and pneumonectomy. It was decided to exclude simple wedge resections since, in light of the minimal resection of parenchyma and the costs sustained for the equipment, they are preferably carried out by VATS.

Description

Inclusion Criteria:

• The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
• The primary pathology is under control or controllable
• Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion Criteria:

• Age >/= ; then 18 years at the moment of surgery
• Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
open (thoracotomy); Nowadays, pulmonary metastasectomy is performed in RATS, VATS or thoracotomy. A thoracotomy is a surgical procedure during which a surgeon accesses the lungs and other nearby organs through an incision in the chest wall.
RATS (robot-assisted thoracoscopic surgery); RATS is a minimally invasive surgical technique allowing enhanced view, accurate and complex movements, and high ergonomics for the surgeon.
VATS (video-assisted thoracoscopic surgery); VATS is minimally invasive thoracic surgery that does not use a formal thoracotomy incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele
• Collaborators: Istituto Clinico Humanitas; Istituto Europeo di Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: video-assisted thoracoscopic surgery; robot-assisted thoracoscopic surgery; pulmonary metastasectomy
• Other Study ID Numbers: CE: 23/INT/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No