Robotic Surgery in Pulmonary Metastasectomy — ROME  

Primary Solid Tumors Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Primary Solid Tumors

• NCT number: NCT06466070
• Study type: Observational
• Source: Scientific Institute San Raffaele
• Status: Enrolling by invitation
• Start date: July 11, 2023
• Completion date: December 31, 2026