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

December 11, 2024 updated by: Pierluigi Novellis, Scientific Institute San Raffaele

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

472

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pierluigi Novellis, Medical Doctor
Phone Number: +39 0226437202
Email: novellis.pierluigi@hsr.it

Study Locations

Italy
- - Milan, Italy, 20141
    - Recruiting
    - Istituto Europeo di Oncologia
    - Contact:
      
      Lorenzo Spiaggiari, MD
      
      Email: lorenzo.spaggiari@ieo.it
    - Contact:
      
      Monica Casiraghi, MD
      
      Email: monica.casiraghi@ieo.it
  - Milan, Italy, 20132
    - Recruiting
    - Scientific Institute Ospedale San Raffaele
    - Contact:
      
      Pierluigi Novellis, MD
      
      Phone Number: +39 0226437202
      
      Email: novellis.pierluigi@hsr.it
  - Rome, Italy, 30151
    - Recruiting
    - Policlinico Universitario Agostino Gemelli
    - Contact:
      
      Dania Nachira, MD
      
      Email: dania.nachira@policlinicogemelli.it
    - Contact:
      
      Stefano Margaritora, MD
      
      Email: stefano.margaritora@policlinicogemelli.it
- Milan
  - Rozzano, Milan, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Giuseppe Marulli, MD
      
      Email: giuseppe.marulli@unimed.eu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from the surgery at 30-90 days after
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.	30-90 days after surgery
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.	30-90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery Time Frame: up to 1 month	Duration of the surgery based on the approach measured in minutes	up to 1 month
Quality of lymphadenectomy Time Frame: up to 1 month	Number of lymphonodes station resected	up to 1 month
Conversion rate Time Frame: up to 1 month	Number of surgery procedures converted	up to 1 month
Survival analysis Time Frame: up to 5 years	Presence or absence of local and distant relapse	up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Institute San Raffaele

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Istituto Clinico Humanitas

Istituto Europeo di Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Estimated)

December 5, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)