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NCT Number: NCT06737107

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

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.

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Key information

Conditions

Early Stage Lung Cancer (I and II) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas, Rozzano, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).

    Complications will be categorized according to the Clavien-Dindo scale.

  2. 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 video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).

    Complications will be categorized according to the Clavien-Dindo scale.

  3. 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 with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.

Secondary outcomes

  1. Duration of surgery

    Time frame: up to 1 month

    Duration of the surgery based on the approach measured in minutes

  2. Quality of lymphadenectomy

    Time frame: up to 1 month

    Number of lymphonodes station resected

  3. Conversion rate

    Time frame: up to 1 month

    Number of surgery procedures converted

  4. Survival analysis

    Time frame: up to 5 years

    Presence or absence of local and distant relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Pierluigi Novellis, Medical Doctor

CONTACT

[email protected]

0226437202 ext. +39

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Istituto Clinico Humanitas
  • Istituto Europeo di Oncologia

Registry information

Official study title

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

Acronym: ANASEGME

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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