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Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT02056041
Collaborator
(none)
336
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hepatectomy

Detailed Description

All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Study Design

Study Type:
Observational
Actual Enrollment :
336 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Hepatectomy for HCC

Patients submitted to surgery for HCC

Procedure: Hepatectomy
Other Names:
  • Liver surgery
  • Liver resection
  • Hepatic resection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of surgery for HCC [90 days]

      The primary endpoint was the validation of our selection criteria for safe hepatectomy for HCC in regards to postoperative complications. The role of total bilirubin and cholinesterases was analzyed together with other clinical parameters.

    Secondary Outcome Measures

    1. Score systems HCC [90 days]

      The secondary endpoint was the testing of the most common score systems for HCC, which are the CPT score, the MELD score, and the APRI score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • any patient with HCC submitted to hepatic resection at our Unit in the established frame time
    Exclusion Criteria:
    • any patient with missing data or lost at follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Humanitas Research Hospital Rozzano, Milan Italy 20089

    Sponsors and Collaborators

    • University of Milan

    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:
    NCT02056041
    Other Study ID Numbers:
    • SafeSurgeryHCC
    First Posted:
    Feb 5, 2014
    Last Update Posted:
    Jun 18, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Liver Extracts

    Study Results

    No Results Posted as of Jun 18, 2014