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
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Biopsy confirmed colorectal cancer with liver metastasis

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565811

Locations
Korea, Republic of
Won-Suk Lee Recruiting
Incheon, Korea, Republic of, 405-760
Contact: WS Lee, MD,Ph.D    82-32-3289 ext 3289    gachonlws@gmail.com   
Principal Investigator: WS Lee, MD         
Principal Investigator: Won-Suk Lee, MD         
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Won-Suk Lee, MD Gil Hospital
  More Information

No publications provided

Responsible Party: Won-Suk Lee, Assistant Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01565811     History of Changes
Other Study ID Numbers: girba2291
Study First Received: March 27, 2012
Last Updated: March 27, 2012
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014