Clinical trial NCT06466070: Robotic Surgery in Pulmonary Metastasectomy
Official title: The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Primary Solid Tumors
Keywords: pulmonary metastasectomy
robot-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
Collaborators: name: Istituto Europeo di Oncologia
name: Istituto Clinico Humanitas
First posted: 2024-06-20
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PERIOPERATIVE OUTCOME
timeFrame: from hospitalization to the discharge date at maximum one week
measure: PERIOPERATIVE OUTCOME 2
timeFrame: from surgery to time of pathological response
Secondary outcomes:
measure: PATHOLOGICAL OUTCOME
timeFrame: from surgery to time of pathological response
measure: PATHOLOGICAL OUTCOME 2
timeFrame: from surgery to time of pathological response
measure: PATHOLOGICAL OUTCOME 3
timeFrame: from surgery to time of pathological response
measure: PATHOLOGICAL OUTCOME 4
timeFrame: from surgery to time of pathological response
Other outcomes:
measure: ONCOLOGICAL LONG TERM OUTCOME
timeFrame: From the discharge date to the follow up at 1year; 3 years and 5 years
measure: ONCOLOGICAL LONG TERM OUTCOME 1
timeFrame: From the discharge date to the follow up at 1year; 3 years and 5 years
Locations:
city: Rome
country: Italy
facility: IFO - Istituto Nazionale Tumori Regina Elena di Roma
state: Italy / Rome
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
state: Italy/Milan
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Italy/Milan
Study officials:
References: