Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

This study is currently recruiting participants.

Verified by Chung-Ang University, April 2008

Sponsored by:	Chung-Ang University
Information provided by:	Chung-Ang University
ClinicalTrials.gov Identifier:	NCT00654342

Purpose

The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.

Condition	Intervention
Sentinel Lymph Node Biopsy Colon Cancer	Procedure: Intraoperative injection (in vivo) Procedure: Postoperative injection (ex vivo)

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

Further study details as provided by Chung-Ang University:

Primary Outcome Measures:

Accuracy & sensitivity of sentinel lymph node mapping [ Time Frame: After confirmed pathological report ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 In vivo injection group	Procedure: Intraoperative injection (in vivo) Intraoperative injection
2 Ex vivo injection group	Procedure: Postoperative injection (ex vivo) postoperative injection

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage I - III colon cancer patients

Exclusion Criteria:

cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654342

Contacts

Contact: In-Taik Chang, M.D., Ph.D.	82-2-6299-1562	caumed5@naver.com
Contact: Jun Seok Park, M.D.	82-2-6299-1548	doctorsupreme@gmail.com

Locations

Korea, Republic of
Department of Surgery, Chung-Ang university Hospital	Recruiting
Seoul, Korea, Republic of, 156-755

Sponsors and Collaborators

Chung-Ang University

More Information

Responsible Party:	Chung-Ang University Hospital ( Department of Surgery, colleage of medicine, )
Study ID Numbers:	caugs_01
Study First Received:	April 2, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00654342
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chung-Ang University:

Sentinel lymph node-colon cancer

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009