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

August 28, 2015 updated by: Won-Suk Lee, Gachon University Gil Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Biopsy confirmed colorectal cancer with liver metastasis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complication rate
Time Frame: within 3months
within 3months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Won-Suk Lee, MD, Gil Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • girba2291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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