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Clinical Trials/NCT06626243
NCT06626243
Recruiting
N/A

An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy

Scientific Institute San Raffaele6 sites in 2 countries140 target enrollmentSeptember 30, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non-Small Cell Lung Cancer
Sponsor
Scientific Institute San Raffaele
Enrollment
140
Locations
6
Primary Endpoint
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.

There are no risks for the patients, as this is a retrospective data collection.

Detailed Description

The use of neoadjuvant chemo-immunotherapy for the treatment of non-small cell lung cancer (NSCLC) is increasing. However, there is limited research comparing the feasibility and oncologic efficacy of robot-assisted thoracoscopic surgery (RATS), video-assisted thoracoscopic surgery (VATS), and open lung resection, in patients already treated with neoadjuvant chemo-immunotherapy. This study aims to evaluate the benefits of RATS compared to VATS and open surgery in terms of short-term outcomes for patients with NSCLC undergoing neoadjuvant chemo-immunotherapy. All adult patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy will be included. Patients are divided into three groups: robotic lung resection; video-assisted thoracoscopic (VATS) lung resection; open lung resection.

Registry
clinicaltrials.gov
Start Date
September 30, 2024
End Date
October 15, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Scientific Institute San Raffaele
Responsible Party
Principal Investigator
Principal Investigator

Pierluigi Novellis

Principal Investigator

Scientific Institute San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
  • Received neoadjuvant chemo-immunotherapy or immunotherapy alone
  • Age \>= 18 years old at the moment of surgery

Exclusion Criteria

  • Age \<18 years old at the moment of surgery

Outcomes

Primary Outcomes

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 VATS approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.

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 who received neoadjuvant chemo-immunotherapy. 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 who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.

Secondary Outcomes

  • Duration of surgery(from 30 days after surgery)
  • Quality of lymphadenectomy(from 30 days after surgery)
  • Conversion rate(from 30 days after surgery)
  • Radicality of the resection(from 30 days after surgery)
  • Oncological treatment(from 30 days after surgery)
  • Survival analysis(from 3 to 5 years after surgery)

Study Sites (6)

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