Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Early Stage Lung Cancer (I and II), Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach
Overview
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.
Primary outcome measures
- The perioperative complications of robotic approach [Time frame: 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 perioperative complications of the open approach [Time frame: 30-90 days after surgery]
Secondary outcome measures (4)
- Duration of surgery [Time frame: up to 1 month]
- Quality of lymphadenectomy [Time frame: up to 1 month]
- Conversion rate [Time frame: up to 1 month]
- Survival analysis [Time frame: up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 4 centers
- Istituto Clinico Humanitas — Rozzano
- Scientific Institute Ospedale San Raffaele — Milan
- Istituto Europeo di Oncologia — Milan
- Policlinico Universitario Agostino Gemelli — Rome
Identifiers
NCT: NCT06737107 · 15/INT/2023