Early Stage Lung Cancer (I and II)ANASEGMENCT06737107
Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer
An observational study of Early Stage Lung Cancer (I and II) and Non-Small Cell Lung Cancer, run by Scientific Institute San Raffaele at 4 sites in Italy.
Trial summary
The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Lung Cancer (I and II), Non-Small Cell Lung Cancer
- How many people
- 472 participants
- Where
- 4 sitesItaly
- Study dates
- 26 Nov 2024to 31 May 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: Patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy (case) and video-assisted thoracoscopic (VATS) or open segmentectomy (control)
Who may be able to join
- Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.
- Age > then 18 years at the moment of surgery
Who cannot join
- Age < then 18 years at the moment of surgery
- diagnosis other than NSCLC
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Scientific Institute Ospedale San Raffaele
Milan, 20132
Pierluigi Novellis, MD, 0226437202 ext. +39, novellis.pierluigi@hsr.it
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Lorenzo Spiaggiari, MD, lorenzo.spaggiari@ieo.it
Monica Casiraghi, MD, monica.casiraghi@ieo.it
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, 30151
Stefano Margaritora, MD, stefano.margaritora@policlinicogemelli.it
Dania Nachira, MD, dania.nachira@policlinicogemelli.it
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milan, 20089
Giuseppe Marulli, MD, giuseppe.marulli@unimed.eu
About this study
Official title: Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach
The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.
Read the detailed description
Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.
What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).
This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.
In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.
The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
The population includes: all patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy and VATS or open segmentectomy, reaching a total of 472 cases of which 50 from our hospital.
- Keywords
- Video-Assisted Thoracoscopic Surgery, open approach, Robot-Assisted Thoracoscopic Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| Case group : Robotic Approach | Patients with a pre or post-operative diagnosis of NSCLC surgically treated with robotic segmentectomy from 1st January 2010 to the 31st to December 2023 | |
| Control group: video-assisted thoracoscopic surgery (VATS) and open | Patients with a pre or post-operative diagnosis of NSCLC surgically treated with video-assisted thoracoscopic surgery (VATS) and open segmentectomy from 1st January 2010 to the 31st to December 2023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perioperative complications of robotic approach
The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).
Complications will be categorized according to the Clavien-Dindo scale.
Measured: from the surgery at 30-90 days after
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).
Complications will be categorized according to the Clavien-Dindo scale.
Measured: 30-90 days after surgery
The perioperative complications of the open approach
The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Measured: 30-90 days after surgery
Secondary outcomes (4)
Duration of surgery
Duration of the surgery based on the approach measured in minutes
Measured: up to 1 month
Quality of lymphadenectomy
Number of lymphonodes station resected
Measured: up to 1 month
Conversion rate
Number of surgery procedures converted
Measured: up to 1 month
Survival analysis
Presence or absence of local and distant relapse
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start26 Nov 2024
- Primary completion5 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Lung Cancer (I and II)Studies 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
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituto Europeo di Oncologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Pierluigi Novellis, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737107
- Sponsor's protocol ID
- 15/INT/2023
- Acronym
- ANASEGME
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 17 Dec 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach
- ClinicalTrials.gov ID
- NCT06737107
- Acronym / sponsor ID
- ANASEGME / 15/INT/2023
- Keywords
- Video-Assisted Thoracoscopic Surgery, open approach, Robot-Assisted Thoracoscopic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituto Europeo di Oncologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Dec 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 a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.
Detailed description
Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.
What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).
This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.
In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.
The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
The population includes: all patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy and VATS or open segmentectomy, reaching a total of 472 cases of which 50 from our hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group : Robotic Approach | – | –Patients with a pre or post-operative diagnosis of NSCLC surgically treated with robotic segmentectomy from 1st January 2010 to the 31st to December 2023 |
| Control group: video-assisted thoracoscopic surgery (VATS) and open | – | –Patients with a pre or post-operative diagnosis of NSCLC surgically treated with video-assisted thoracoscopic surgery (VATS) and open segmentectomy from 1st January 2010 to the 31st to December 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy (case) and video-assisted thoracoscopic (VATS) or open segmentectomy (control)
Key inclusion criteria (2 listed)
- Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.
- Age > then 18 years at the moment of surgery
Key exclusion criteria (2 listed)
- Age < then 18 years at the moment of surgery
- diagnosis other than NSCLC
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
The perioperative complications of robotic approach
Time frame: from the surgery at 30-90 days after
The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
Time frame: 30-90 days after surgery
The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of the open approach
Time frame: 30-90 days after surgery
The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
4 secondary outcomes
Duration of surgery
Time frame: up to 1 month
Quality of lymphadenectomy
Time frame: up to 1 month
Conversion rate
Time frame: up to 1 month
Survival analysis
Time frame: up to 5 years
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 17 Dec 2024.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Stage Lung Cancer (I and II) and Non-Small Cell Lung Cancer, run by Scientific Institute San Raffaele at 4 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 2 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Pierluigi Novellis, Medical Doctor (0226437202 ext. +39, novellis.pierluigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perioperative complications of robotic approach (time frame: from the surgery at 30-90 days after). The study lists 3 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 17 Dec 2024.