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

Colorectal Cancer With Liver Metastasis Clinical Trial

— LN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565811
• Other study ID #: girba2291
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2012
• Last updated: August 28, 2015
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer With Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Won-Suk Lee	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate		within 3months	No
Secondary	To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival		3 years	No