Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
Conditions
Colorectal Cancer With Liver Metastasis
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
colon neoplasm, rectal neoplasm, liver metastasis
Study Type
Observational
Study Phase
Phase 2
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: perihepatic lymphadenectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Won-Suk Lee
Incheon, Korea, Republic of
Status: Recruiting
Contact: WS Lee, MD,Ph.D - 82-32-3289 - gachonlws@gmail.com
Start Date
August 2010
Completion Date
August 2013
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page