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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01565811

Acronym

Enrollment

Registered

2012-03-29

Start date

2010-08-31

Completion date

2013-12-31

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer With Liver Metastasis

Keywords

colon neoplasm, rectal neoplasm, liver metastasis

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.

Interventions

PROCEDUREperihepatic 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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
complication rate	within 3months

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026