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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733200
• Other study ID #: chenxp002
• Status: Completed
• Phase: N/A
• First received: August 8, 2008
• Last updated: December 10, 2009

Study information

• Verified date: August 2008
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Years to 72 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatectomy
• Klatskin's Tumor
• Surgical Treatment

Intervention

Procedure:
• Minor or Major Liver Resection

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Hepatic Surgery Clinical Research Centre of Hubei, China, Ministry of Health, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade.