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

This study has been completed.

Sponsor:

Collaborators:

Ministry of Health, China

Hepatic Surgery Clinical Research Centre of Hubei, China

Information provided by:

Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00733200

First received: August 8, 2008

Last updated: December 10, 2009

Last verified: August 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2008
Last Updated Date	December 10, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: August 11, 2008)	On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00733200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
Official Title ^ICMJE	Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Cholangiocarcinoma Surgical Treatment Hepatectomy
Intervention ^ICMJE	Procedure: Minor or Major Liver Resection
Study Arm (s)	No Intervention: Control group Intervention: Procedure: Minor or Major Liver Resection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	26 Years to 72 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00733200
Other Study ID Numbers ^ICMJE	chenxp002
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Huazhong University of Science and Technology
Collaborators ^ICMJE	Ministry of Health, China Hepatic Surgery Clinical Research Centre of Hubei, China
Investigators ^ICMJE	Not Provided
Information Provided By	Huazhong University of Science and Technology
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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