Robotic Surgery in Pulmonary Metastasectomy

NCT ID: NCT06466070

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-11

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Primary Solid Tumors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

VATS (video-assisted thoracoscopic surgery)

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Europeo di Oncologia

OTHER

Sponsor Role collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Stefano Viscardi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IFO - Istituto Nazionale Tumori Regina Elena di Roma

Rome, Italy / Rome, Italy

Site Status

Istituto Europeo di Oncologia

Milan, Italy/Milan, Italy

Site Status

Istituto Clinico Humanitas

Rozzano, Italy/Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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CE: 23/INT/2023

Identifier Type: -

Identifier Source: org_study_id

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