NON-COlorectal Liver METastases Undergoing Liver Resection
ConditionLiver Metastases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
About this trial
Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signature informed consent
Age ≥ 18 years
Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
Liver resection performed.
Disqualifiers
ASA IV
Severe psychiatric pathology
Unable to follow a clinical examination pattern during observation.
Patient submitted exclusively to interventional locoregional procedures other than liver resection.
Trial population
All patients with a diagnosis, based on imaging methods and histologically confirmed, of NCRLM, consecutively referred to centres with expertise in hepatobiliary surgery will be evaluated for inclusion. For the diagnosis and staging of disease the participating centres will refer to the guidelines for NCRLM, together with the established clinical habits present in each centre
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
liver resection
Procedure/SurgeryResection of non-colorectal liver metastases
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Overall Survival
Overall Survival defined as the time elapsed between the date of resective surgery and the date of death for any reason. Patients who are surviving at the end of observation will be considered "censored" at the date of the last available follow-up.
Time frame
From date of enrollment until the date of death from any cause assessed up to 36 monthsSecondary outcomes
1
Disease-free Survival
Disease-free Survival defined as the time from resective surgery to the date of first relapse or last available follow-up, whichever occurs first
Time frame
From date of enrollement until the date of first documented progression assessed up to 36 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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