NCT06737107

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

Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 472 (estimated)
• Sponsor: Scientific Institute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Stage Lung Cancer (I and II)
• Non-Small Cell Lung Cancer

Timeline

• Start date: 2024-11-26
• Primary completion: 2025-12-05
• Completion: 2026-05-31
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

4 sites across 1 country: Italy