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

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ClinicalTrials.gov Identifier: NCT00654342
Recruitment Status : Unknown
Verified April 2008 by Chung-Ang University.
Recruitment status was:  Recruiting
First Posted : April 8, 2008
Last Update Posted : April 8, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Sentinel Lymph Node Biopsy Colon Cancer Procedure: Intraoperative injection (in vivo) Procedure: Postoperative injection (ex vivo)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer
Study Start Date : October 2007
Estimated Primary Completion Date : February 2009
Arms and Interventions

Arm Intervention/treatment
In vivo injection group
Procedure: Intraoperative injection (in vivo)
Intraoperative injection
Ex vivo injection group
Procedure: Postoperative injection (ex vivo)
postoperative injection

Outcome Measures

Primary Outcome Measures :
  1. Accuracy & sensitivity of sentinel lymph node mapping [ Time Frame: After confirmed pathological report ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654342

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

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: Department of Surgery, colleage of medicine,, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT00654342     History of Changes
Other Study ID Numbers: caugs_01
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: April 8, 2008
Last Verified: April 2008

Keywords provided by Chung-Ang University:
Sentinel lymph node-colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases