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

Gachon University Gil Medical Center30 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer With Liver Metastasis

Interventions

perihepatic lymphadenectomyPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Won-Suk Lee

Incheon, South Korea

Outcomes

Primary Outcomes

complication rate

Time frame: within 3months

Secondary Outcomes

To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.