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Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

Primary Purpose

Cholangiocarcinoma, Surgical Treatment, Hepatectomy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minor or Major Liver Resection
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Cholangiocarcinoma focused on measuring Minor Liver Resection, Major Liver Resection, Hilar

Eligibility Criteria

26 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally

Exclusion Criteria:

  • not in accordance with the above criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2008
    Last Updated
    December 10, 2009
    Sponsor
    Huazhong University of Science and Technology
    Collaborators
    Ministry of Health, China, Hepatic Surgery Clinical Research Centre of Hubei, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00733200
    Brief Title
    Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
    Official Title
    Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Huazhong University of Science and Technology
    Collaborators
    Ministry of Health, China, Hepatic Surgery Clinical Research Centre of Hubei, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators conducted a prospective study to determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in 138 patients with hilar cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.
    Detailed Description
    Objective: To determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in patients with hilar cholangiocarcinoma (HC). Summary Background Data: For HC treated with hepatectomy, the extent of liver resection remains controversial despite extensive studies. Methods: From January 2000 to December 2007, we prospectively studied patients who received surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%) underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion; and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein invasion, or type IV HC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholangiocarcinoma, Surgical Treatment, Hepatectomy
    Keywords
    Minor Liver Resection, Major Liver Resection, Hilar

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Minor or Major Liver Resection
    Primary Outcome Measure Information:
    Title
    On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally Exclusion Criteria: not in accordance with the above criteria

    12. IPD Sharing Statement

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    Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

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