Robotic Surgery in Pulmonary Metastasectomy

• Conditions: Primary Solid Tumors

• Registration Number: NCT06466070
• Lead Sponsor: Scientific Institute San Raffaele

Brief 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.

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 Timeline

• Study Start: 2023-07-11
• Study First Submitted: 2024-05-29
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PERIOPERATIVE OUTCOME	from hospitalization to the discharge date at maximum one week	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.
PERIOPERATIVE OUTCOME 2	from surgery to time of pathological response	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.

Secondary Outcome Measures

Name	Time	Method
PATHOLOGICAL OUTCOME 3	from surgery to time of pathological response	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.
PATHOLOGICAL OUTCOME 4	from surgery to time of pathological response	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.
PATHOLOGICAL OUTCOME	from surgery to time of pathological response	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.
PATHOLOGICAL OUTCOME 2	from surgery to time of pathological response	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.

Trial Locations

Locations (3)

IFO - Istituto Nazionale Tumori Regina Elena di Roma; 🇮🇹 Rome, Italy / Rome, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy/Milan, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy/Milan, Italy