Robotic Surgery in Pulmonary Metastasectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
Overview
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.
Primary outcome measures
- PERIOPERATIVE OUTCOME [Time frame: from hospitalization to the discharge date at maximum one week]
- PERIOPERATIVE OUTCOME 2 [Time frame: from surgery to time of pathological response]
Secondary outcome measures (4)
- PATHOLOGICAL OUTCOME [Time frame: from surgery to time of pathological response]
- PATHOLOGICAL OUTCOME 2 [Time frame: from surgery to time of pathological response]
- PATHOLOGICAL OUTCOME 3 [Time frame: from surgery to time of pathological response]
- PATHOLOGICAL OUTCOME 4 [Time frame: from surgery to time of pathological response]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 3 centers
- IFO - Istituto Nazionale Tumori Regina Elena di Roma — Rome
- Istituto Europeo di Oncologia — Milan
- Istituto Clinico Humanitas — Rozzano
Identifiers
NCT: NCT06466070 · CE: 23/INT/2023