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
Recruitment status was Recruiting
Sponsor:
Chung-Ang University
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
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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 |
| 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
No publications provided
| 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 Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013