Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis

NCT ID: NCT01565811

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-12-31

Brief Summary

Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.

Detailed Description

Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.

Conditions

Colorectal Cancer With Liver Metastasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatic pedicle lymph node Involvement

Intervention Type: perihepatic lymphadenectomy(surgical procedure)

perihepatic lymphadenectomy

Intervention Type: PROCEDURE

Hepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct).

Interventions

perihepatic lymphadenectomy

Hepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. first hepatectomy;

2. age <75 years;

3. absence of severe cardiovascular,pulmonary, or other associated diseases;

4. absence of other malignant disease;

5. absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and

6. complete resection of liver metastases confirmed during surgery.

Exclusion Criteria

1. HNPCC

2. FAP

3. patient who refuses perihepatic lymphadnectomy

4. medical condition in which surgery cannot be tolerated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won-Suk Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won-Suk Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Gil Hospital

Locations

Won-Suk Lee

Incheon, , South Korea

Countries

South Korea

Other Identifiers

girba2291

Identifier Type: -

Identifier Source: org_study_id