Clinical trial NCT06737107: Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer
Official title: Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Stage Lung Cancer (I and II)
Non-Small Cell Lung Cancer
Keywords: Video-Assisted Thoracoscopic Surgery
open approach
Robot-Assisted Thoracoscopic Surgery
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
Collaborators: name: Istituto Clinico Humanitas
name: Istituto Europeo di Oncologia
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2024-12-17
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The perioperative complications of robotic approach
timeFrame: from the surgery at 30-90 days after
measure: The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
timeFrame: 30-90 days after surgery
measure: The perioperative complications of the open approach
timeFrame: 30-90 days after surgery
Secondary outcomes:
measure: Duration of surgery
timeFrame: up to 1 month
measure: Quality of lymphadenectomy
timeFrame: up to 1 month
measure: Conversion rate
timeFrame: up to 1 month
measure: Survival analysis
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Milan
country: Italy
facility: Scientific Institute Ospedale San Raffaele
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
References: