Study Results
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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ENROLLING_BY_INVITATION
1650 participants
OBSERVATIONAL
2023-07-11
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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 primary pathology is under control or controllable
* Absence of extrapulmonary metastases that are not controlled or controllable
Exclusion Criteria
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above.
18 Years
ALL
No
Sponsors
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Istituto Europeo di Oncologia
OTHER
Istituto Clinico Humanitas
OTHER
Scientific Institute San Raffaele
OTHER
Responsible Party
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Stefano Viscardi
MD
Locations
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IFO - Istituto Nazionale Tumori Regina Elena di Roma
Rome, Italy / Rome, Italy
Istituto Europeo di Oncologia
Milan, Italy/Milan, Italy
Istituto Clinico Humanitas
Rozzano, Italy/Milan, Italy
Countries
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Other Identifiers
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CE: 23/INT/2023
Identifier Type: -
Identifier Source: org_study_id
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