NON-COlorectal Liver METastases Undergoing Liver Resection

NCT06542926 | Not Yet Recruiting

• 1 other identifier: NONCOLMET01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Metastases

Outcome Measures

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.

  From date of enrollment until the date of death from any cause assessed up to 36 months

Secondary Outcomes (1)

• Disease-free Survival

  From date of enrollement until the date of first documented progression assessed up to 36 months

Interventions

liver resection PROCEDURE

Resection of non-colorectal liver metastases

Also known as: hepatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Signature informed consent
• Age ≥ 18 years
• Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
• Liver resection performed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Matteo Donadon, MD, PhD

  AOU della Carità, Novara, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Donadon, MD, PhD

CONTACT

003903213733045; matteo.donadon@uniupo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share