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

This study has been completed.
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center Identifier:
First received: March 27, 2012
Last updated: August 28, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Colorectal Cancer With Liver Metastasis
Procedure: perihepatic lymphadenectomy
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • complication rate [ Time Frame: within 3months ]

Secondary Outcome Measures:
  • To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival [ Time Frame: 3 years ]

Enrollment: 30
Study Start Date: August 2010
Study Completion Date: December 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatic pedicle lymph node Involvement
Intervention Type: perihepatic lymphadenectomy(surgical procedure)
Procedure: perihepatic 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).

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Biopsy confirmed colorectal cancer with liver metastasis

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01565811

Korea, Republic of
Won-Suk Lee
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Won-Suk Lee, MD Gil Hospital
  More Information

Responsible Party: Won-Suk Lee, Assistant Professor, Gachon University Gil Medical Center Identifier: NCT01565811     History of Changes
Other Study ID Numbers: girba2291
Study First Received: March 27, 2012
Last Updated: August 28, 2015

Keywords provided by Gachon University Gil Medical Center:
colon neoplasm, rectal neoplasm, liver metastasis

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases processed this record on May 23, 2017