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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer With Liver Metastasis

Intervention / Treatment
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* Procedure: perihepatic lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first hepatectomy; age <75 years; absence of severe cardiovascular,pulmonary, or other associated diseases; absence of other malignant disease; 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 complete resection of liver metastases confirmed during surgery. Exclusion Criteria: HNPCC FAP patient who refuses perihepatic lymphadnectomy medical condition in which surgery cannot be tolerated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatic pedicle lymph node Involvement<br>Intervention Type: perihepatic lymphadenectomy(surgical procedure) | Procedure: perihepatic lymphadenectomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | within 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon neoplasm, rectal neoplasm, liver metastasis