Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer

NCT ID: NCT06737107

Last Updated: 2024-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Stage Lung Cancer (I and II) Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Age \< then 18 years at the moment of surgery
* diagnosis other than NSCLC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Clinico Humanitas

OTHER

Sponsor Role collaborator

Istituto Europeo di Oncologia

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pierluigi Novellis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Istituto Europeo di Oncologia

Milan, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pierluigi Novellis, Medical Doctor

Role: CONTACT

0226437202 ext. +39

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Giuseppe Marulli, MD

Role: primary

Pierluigi Novellis, MD

Role: primary

0226437202 ext. +39

Lorenzo Spiaggiari, MD

Role: primary

Monica Casiraghi, MD

Role: backup

Stefano Margaritora, MD

Role: primary

Dania Nachira, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15/INT/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.