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
About this trial
This is an interventional trial for Cholangiocarcinoma focused on measuring Minor Liver Resection, Major Liver Resection, Hilar
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
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
NCT ID
NCT00733200
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
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
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Primary Completion Date
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Study Completion Date
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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
Learn more about this trial
Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
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