Robotic Surgery in Pulmonary Metastasectomy (ROME)

Scientific Institute San Raffaele

Status: Invitation-only

Conditions: Primary Solid Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT06466070

CE: 23/INT/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,650 participants in 3 patient groups

open (thoracotomy)

Description:

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)

Description:

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)

Description:

VATS is minimally invasive thoracic surgery that does not use a formal thoracotomy incision.