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Enrolling by Invitation

NCT Number: NCT06466070

Robotic Surgery in Pulmonary Metastasectomy

The study is observational, multicenter retrospective and will involve multiple research centers. The aim is to outline the indications for surgical management with robot-assisted pulmonary metastasectomy through a confrontation of robot-assisted thoracoscopic surgery (RATS) with video-assisted thoracoscopic surgery (VATS) and thoracotomy. The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). There are no risks for the patients, as this is a retrospective data collection.

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Key information

Conditions

Primary Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IFO - Istituto Nazionale Tumori Regina Elena di Roma, Rome, Italy / Rome, Italy

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About this study

The investigators will identify selection criteria according to ASA score (American Society of Anaesthesiologists physical status classification system ) and co-morbidities, respiratory function, control and staging of the primary pathology, number and position of metastases. The investigators will assess the robotic approach performance in the different anatomical resections (lobectomies, bilobectomies, segmentectomies,pneumectomies) considering potential intra- and post-operative complications, over than rates of positive margins.

It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), or with a traditional open approach. More precisely, it will compare RATS vs VATS as well as RATS vs open.

It was decided to exclude simple wedge resections since, in light of the minimal resection of parenchyma and the costs sustained for the equipment, they are preferably carried out by VATS.

Criteria for the inclusion of patients:

  • The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
  • The primary pathology is under control or controllable
  • Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion criteria

  • Age >/=; then 18 years at the moment of surgery
  • Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
  • The primary pathology is under control or controllable
  • Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion criteria

  • Age >/= ; then 18 years at the moment of surgery
  • Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

Treatment and study plan

Primary outcomes

  1. PERIOPERATIVE OUTCOME

    Time frame: from hospitalization to the discharge date at maximum one week

    The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy.

    The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing intra- and post-operative complications, which will be categorized according to Clavien-Dindo scale.

  2. PERIOPERATIVE OUTCOME 2

    Time frame: from surgery to time of pathological response

    The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy.

    The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing the rate of resection radicality.

Secondary outcomes

  1. PATHOLOGICAL OUTCOME

    Time frame: from surgery to time of pathological response

    The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the number of cases which underwent radical lymphnode dissection or lymphnode sampling.

  2. PATHOLOGICAL OUTCOME 2

    Time frame: from surgery to time of pathological response

    The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the number of resected hilar and mediastinal lymphnodes.

  3. PATHOLOGICAL OUTCOME 3

    Time frame: from surgery to time of pathological response

    The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the frequency of positive lymphnodes.

  4. PATHOLOGICAL OUTCOME 4

    Time frame: from surgery to time of pathological response

    The investigators will measure the impact of the robotic approach on lymphadenectomy comparing the cases from the Robotic Assisted Thoracic Surgery (RATS) group with the ones from Video Assisted Thoracic Surgery (VATS) and open group, by analizing the frequency of unexpected positive lymphnodes.

Other outcomes

  1. ONCOLOGICAL LONG TERM OUTCOME

    Time frame: From the discharge date to the follow up at 1year; 3 years and 5 years

    The investigators will evaluate the potential oncological benefit of Robotic Assisted Thoracic Surgery (RATS) by analizing Overall Survival (OS) of patients subjected to robotic resections, compared to Video Assisted Thoracoscopic Surgery (VATS) and open groups.

  2. ONCOLOGICAL LONG TERM OUTCOME 1

    Time frame: From the discharge date to the follow up at 1year; 3 years and 5 years

    The investigators will evaluate the potential oncological benefit of Robotic Assisted Thoracic Surgery (RATS) by analizing Disease-Free Interval (DFI) of patients subjected to robotic resections, compared to Video Assisted Thoracoscopic Surgery (VATS) and open groups.

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Collaborators

  • Istituto Clinico Humanitas
  • Istituto Europeo di Oncologia

Registry information

Official study title

The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study

Acronym: ROME

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Jun 20, 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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