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

NCT06737107 | Recruiting

• 1 other identifier: 15/INT/2023
• Study Type: observational
• Target: 472
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

Video-Assisted Thoracoscopic Surgery; open approach; Robot-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  30-90 days after surgery

Secondary Outcomes (4)

• Duration of surgery

  up to 1 month

• Quality of lymphadenectomy

  up to 1 month

• Conversion rate

  up to 1 month

• Survival analysis

  up to 5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• Age \< then 18 years at the moment of surgery
• diagnosis other than NSCLC

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead
• Istituto Clinico Humanitas: collaborator
• Istituto Europeo di Oncologia: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (4)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, 30151, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Pierluigi Novellis, Medical Doctor

CONTACT

0226437202; novellis.pierluigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 17, 2024
• Study Start: November 26, 2024
• Primary Completion: December 5, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

IT (4)