Robotic Surgery in Pulmonary Metastasectomy

Primary Solid Tumors Clinical Trial

— ROME  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06466070
• Other study ID #: CE: 23/INT/2023
• Status: Enrolling by invitation
• Start date: July 11, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1650
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Solid Tumors

Locations

Country	Name	City	State
Italy	Istituto Europeo di Oncologia	Milan	Italy/Milan
Italy	IFO - Istituto Nazionale Tumori Regina Elena di Roma	Rome	Italy / Rome
Italy	Istituto Clinico Humanitas	Rozzano	Italy/Milan

Sponsors (3)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele	Istituto Clinico Humanitas, Istituto Europeo di Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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