NCT06466070|Enrolling By Invitation
Robotic Surgery in Pulmonary Metastasectomy
ROME
The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
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ROME
The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
Sponsor study identifier
observational
1,650
1 country
3
Study Start
July 11, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2023
Actual (reported)May 29, 2024
Actual (reported)June 20, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
PERIOPERATIVE OUTCOME
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.
from hospitalization to the discharge date at maximum one week
PERIOPERATIVE OUTCOME 2
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.
from surgery to time of pathological response
PATHOLOGICAL OUTCOME
from surgery to time of pathological response
PATHOLOGICAL OUTCOME 2
from surgery to time of pathological response
PATHOLOGICAL OUTCOME 3
from surgery to time of pathological response
PATHOLOGICAL OUTCOME 4
from surgery to time of pathological response
ONCOLOGICAL LONG TERM OUTCOME
From the discharge date to the follow up at 1year; 3 years and 5 years
ONCOLOGICAL LONG TERM OUTCOME 1
From the discharge date to the follow up at 1year; 3 years and 5 years
Nowadays, pulmonary metastasectomy is performed in RATS, VATS or thoracotomy. A thoracotomy is a surgical procedure during which a surgeon accesses the lungs and other nearby organs through an incision in the chest wall.
RATS is a minimally invasive surgical technique allowing enhanced view, accurate and complex movements, and high ergonomics for the surgeon.
VATS is minimally invasive thoracic surgery that does not use a formal thoracotomy incision.
The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy and pneumonectomy. 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.
IFO - Istituto Nazionale Tumori Regina Elena di Roma
Rome, Italy / Rome, 00128, Italy
Istituto Europeo di Oncologia
Milan, Italy/Milan, 20121, Italy
Istituto Clinico Humanitas
Rozzano, Italy/Milan, 20089, Italy
First Submitted
May 29, 2024
First Posted
June 20, 2024
Study Start
July 11, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 20, 2024
Record last verified: 2024-06
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