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NCT00654342 Clinical Trial

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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00654342
Other study ID # caugs_01
Secondary ID
Status Recruiting
Phase N/A
First received April 2, 2008
Last updated April 2, 2008
Start date October 2007

Study information
Verified date April 2008
Source Chung-Ang University
Contact In-Taik Chang, M.D., Ph.D.
Phone 82-2-6299-1562
Email caumed5@naver.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraoperative injection (in vivo)
Intraoperative injection
• Postoperative injection (ex vivo)
postoperative injection

Locations
Country Name City State
Korea, Republic of Department of Surgery, Chung-Ang university Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Chung-Ang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy & sensitivity of sentinel lymph node mapping After confirmed pathological report No
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