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

Completed

• Conditions: Colorectal Cancer With Liver Metastasis
• Interventions: Procedure: perihepatic lymphadenectomy

• Registration Number: NCT01565811
• Lead Sponsor: Gachon University Gil Medical Center

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Study Completion: 2013-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatic pedicle lymph node Involvement	perihepatic lymphadenectomy	Intervention Type: perihepatic lymphadenectomy(surgical procedure)

Primary Outcome Measures

Name	Time	Method
complication rate	within 3months

Secondary Outcome Measures

Name	Time	Method
To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival	3 years

Trial Locations

Locations (1)

Won-Suk Lee; 🇰🇷 Incheon, Korea, Republic of