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Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM

Sponsor
General Hospital Groeninge (Other)
Overall Status
Completed
CT.gov ID
NCT05036265
Collaborator
(none)
200
Enrollment
119.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Laparoscopic Liver Resection for Colorectal Liver Metastases: Retrospective Analysis of Prognostic Factors and Oncological Outcomes in a Single-center Cohort
    Actual Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Mar 15, 2020
    Actual Study Completion Date :
    Aug 5, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Survival outcomes [9 years]

      Overall and disease-free survival (Kaplan-Meier method)

    2. Prognostic factors [9 years]

      Univariate Cox proportional-hazards regression analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients diagnosed with colorectal liver metastases

    • Patients who received laparoscopic liver resection for colorectal liver metastases

    • Patients who received the laparoscopic liver resection between September 2011 and mid-March 2020

    Exclusion Criteria:

    • Patients with contraindication for laparoscopic liver resection

    • Refusal to participate in the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • General Hospital Groeninge

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. M. D'hondt, Dr Mathieu D'Hondt, Principal Investigator, General Hospital Groeninge
    ClinicalTrials.gov Identifier:
    NCT05036265
    Other Study ID Numbers:
    • B396201939301
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. M. D'hondt, Dr Mathieu D'Hondt, Principal Investigator, General Hospital Groeninge
    hepatopancreatobiliary
    laparoscopic liver resection
    colorectal liver metastasis
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Liver Neoplasms

    Study Results

    No Results Posted as of Sep 5, 2021