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Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT02331641
Collaborator
University of Bologna (Other)
554
Enrollment
119
Duration (Months)

Study Details

Study Description

Brief Summary

The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in patients with colorectal liver metastases (CLM) is object of debate. We build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hepatectomy

Detailed Description

The aim of this study is to investigate the outcome of patients with colorectal liver metastases (CLM) undergoing multiple minor hepatectomies (MMH) instead of major hepatectomies (MH). Indeed, the performance of MMH versus MH in patients with CLM is object of debate. For this purpose, the databases at two independent institutions were retrospectively reviewed. To control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used. Among 554 patients, 110 patients undergoing MMH and 110 undergoing MH were matched. They were similar in baseline characteristics, comorbidities, features of the primary tumors, and CLM. Primary outcomes were short- and long-term outcome.

Study Design

Study Type:
Observational
Actual Enrollment :
554 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases. A Propensity Score-matched Dual-institution Analysis.
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Major hepatectomy (MH)

Patients who underwent MH for CLM instead of multiple minor hepatectomy (MMH)

Procedure: Hepatectomy
Removal of a part of the liver
Other Names:
  • Hepatic resection

    		•
    Multiple minor hepatectomy (MMH)

    Patients who underwent MMH for CLM instead of MH

    Procedure: Hepatectomy
    Removal of a part of the liver
    Other Names:
  • Hepatic resection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of postoperative complications after MH or MMH, graded based on the Dindo's classification (Dindo et al. Ann Surg 2004;240:205-13) [up to 90 days after surgery]

    Secondary Outcome Measures

    1. Long-term outcome (overall and disease-free survival) [10 years]

      Typical follow-up after surgery (until death and evidence of recurrence)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of CLM
    Exclusion Criteria:

    • Uncertain diagnosis

    • Lost at follow-up

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Milan
    • University of Bologna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Guido Torzilli, Professor of Surgery, University of Milan
    ClinicalTrials.gov Identifier:
    NCT02331641
    Other Study ID Numbers:
    • MajorVsMinorHepatectomy
    First Posted:
    Jan 6, 2015
    Last Update Posted:
    Jan 6, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Prof. Guido Torzilli, Professor of Surgery, University of Milan
    hepatectomy
    hepatic resection
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Liver Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2015