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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01565811
First received: March 27, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 27, 2012
March 27, 2012
August 2010
March 2012   (final data collection date for primary outcome measure)
complication rate [ Time Frame: within 3months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Biopsy confirmed colorectal cancer with liver metastasis

Colorectal Cancer With Liver Metastasis
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).
Hepatic pedicle lymph node Involvement
Intervention Type: perihepatic lymphadenectomy(surgical procedure)
Intervention: Procedure: perihepatic lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2013
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Korea, Republic of
 
NCT01565811
girba2291
Yes
Won-Suk Lee, Gachon University Gil Medical Center
Gachon University Gil Medical Center
Not Provided
Principal Investigator: Won-Suk Lee, MD Gil Hospital
Gachon University Gil Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP