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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer With Liver Metastasis

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

complication rate

Outcome Time Frame:

within 3months

Safety Issue:

No

Principal Investigator

Won-Suk Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gil Hospital

Authority:

Korea: Institutional Review Board

Study ID:

girba2291

NCT ID:

NCT01565811

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Colorectal Cancer With Liver Metastasis
  • colon neoplasm, rectal neoplasm, liver metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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