Robotic Surgery in Pulmonary Metastasectomy

NCT06466070 | Enrolling By Invitation

• 1 other identifier: CE: 23/INT/2023
• Study Type: observational
• Target: 1,650
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Solid Tumors

Keywords

pulmonary metastasectomy; robot-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• PATHOLOGICAL OUTCOME

  from surgery to time of pathological response

• PATHOLOGICAL OUTCOME 2

  from surgery to time of pathological response

• PATHOLOGICAL OUTCOME 3

  from surgery to time of pathological response

• PATHOLOGICAL OUTCOME 4

  from surgery to time of pathological response

Other Outcomes (2)

• ONCOLOGICAL LONG TERM OUTCOME

  From the discharge date to the follow up at 1year; 3 years and 5 years

• ONCOLOGICAL LONG TERM OUTCOME 1

  From the discharge date to the follow up at 1year; 3 years and 5 years

Study Arms (3)

open (thoracotomy)

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)

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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \>/= ; then 18 years at the moment of surgery
• Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead
• Istituto Europeo di Oncologia: collaborator
• Istituto Clinico Humanitas: collaborator

Study Sites (3)

IFO - Istituto Nazionale Tumori Regina Elena di Roma

Rome, Italy / Rome, 00128, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy/Milan, 20121, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy/Milan, 20089, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 20, 2024
• Study Start: July 11, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

IT (3)