Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorScientific Institute San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years old at the moment of surgery

Trial population

Patients with diagnosed locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, video-assisted thoracoscopic (VATS), and open approaches after receiving neoadjuvant chemo-immunotherapy.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 3 trial groups
Group A: Robotic Approach
Group B: video-assisted thoracoscopic surgery (VATS) Approach
Group C: Open Approach

Trial outcomes

Primary outcomes

1

The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach

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.

Time frame
30-90 days after surgery
2

The perioperative complications of robotic approach

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.

Time frame
from the surgery at 30-90 days after
3

The perioperative complications of the open approach

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.

Time frame
30-90 days after surgery

Secondary outcomes

1

Duration of surgery

Duration of the surgery based on the approach measured in minutes

Time frame
from 30 days after surgery
2

Quality of lymphadenectomy

Number of lymphonodes station resected

Time frame
from 30 days after surgery
3

Conversion rate

Number of surgery procedures converted

Time frame
from 30 days after surgery
4

Radicality of the resection

Radicality of the resection in the approaches

Time frame
from 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scientific Institute San Raffaele

Lead sponsor

Memorial Sloan Kettering Cancer Center

Collaborator

Istituto Clinico Humanitas

Collaborator

Regina Elena Cancer Institute

Collaborator

Baptist Health South Florida

Collaborator

West Virginia University

Collaborator