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Completed

NCT Number: NCT01565811

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perihepatic lymphadenectomy

Procedure

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).

Primary outcomes

  1. complication rate

    Time frame: within 3months

Secondary outcomes

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Acronym: LN

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Mar 29, 2012
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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