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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Chung-Ang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chung-Ang University
ClinicalTrials.gov Identifier:
NCT00654342
First received: April 2, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 2, 2008
April 2, 2008
October 2007
February 2009   (final data collection date for primary outcome measure)
Accuracy & sensitivity of sentinel lymph node mapping [ Time Frame: After confirmed pathological report ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Sentinel Lymph Node Biopsy
  • Colon Cancer
  • Procedure: Intraoperative injection (in vivo)
    Intraoperative injection
  • Procedure: Postoperative injection (ex vivo)
    postoperative injection
  • 1
    In vivo injection group
    Intervention: Procedure: Intraoperative injection (in vivo)
  • 2
    Ex vivo injection group
    Intervention: Procedure: Postoperative injection (ex vivo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
 
NCT00654342
caugs_01
No
Department of Surgery, colleage of medicine,, Chung-Ang University Hospital
Chung-Ang University
Not Provided
Not Provided
Chung-Ang University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP