Primary Solid TumorsROMENCT06466070
Robotic Surgery in Pulmonary Metastasectomy
An observational study of Primary Solid Tumors, run by Scientific Institute San Raffaele at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Solid Tumors
- How many people
- 1,650 participants
- Where
- 3 sitesItaly
- Study dates
- 11 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age >/= ; then 18 years at the moment of surgery
- Patients who cannot undergo surgery, as they do not meet the conditions outlined above.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
Istituto Europeo di Oncologia
Milan, Italy/Milan, 20121
IFO - Istituto Nazionale Tumori Regina Elena di Roma
Rome, Italy / Rome, 00128
Istituto Clinico Humanitas
Rozzano, Italy/Milan, 20089
About this study
Official title: The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
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.
Read the 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:
- 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.
- Conditions
- Primary Solid Tumors
- Keywords
- pulmonary metastasectomy, robot-assisted thoracoscopic surgery, video-assisted thoracoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from surgery to time of pathological response
Secondary outcomes (4)
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.
Measured: from surgery to time of pathological response
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.
Measured: from surgery to time of pathological response
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.
Measured: from surgery to time of pathological response
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.
Measured: from surgery to time of pathological response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start11 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Europeo di Oncologia, Istituto Clinico Humanitas
- Responsible party
- Principal investigator, Stefano Viscardi, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466070
- Sponsor's protocol ID
- CE: 23/INT/2023
- Acronym
- ROME
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06466070
- Acronym / sponsor ID
- ROME / CE: 23/INT/2023
- Conditions
- Primary Solid Tumors
- Keywords
- pulmonary metastasectomy, robot-assisted thoracoscopic surgery, video-assisted thoracoscopic surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Collaborators
- Istituto Europeo di Oncologia, Istituto Clinico Humanitas
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age >/= ; then 18 years at the moment of surgery
- Patients who cannot undergo surgery, as they do not meet the conditions outlined above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PERIOPERATIVE OUTCOME
Time frame: from hospitalization to the discharge date at maximum one week
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.
PERIOPERATIVE OUTCOME 2
Time frame: from surgery to time of pathological response
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Related trials for Primary Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
RecruitingPhase 2/3
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Solid Cancer
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Solid Tumors, run by Scientific Institute San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERIOPERATIVE OUTCOME (time frame: from hospitalization to the discharge date at maximum one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.