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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. The completion date has passed and the status has not been verified in more than two years.
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
  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)

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

Resource links provided by NLM:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Department of Surgery, Chung-Ang university Hospital
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 
Study First Received: April 2, 2008
Last Updated: April 2, 2008
Health Authority: Korea: Food and Drug Administration

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on December 05, 2016