Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 2, 2008
CompletedFirst Posted
Study publicly available on registry
April 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedApril 8, 2008
April 1, 2008
1.3 years
April 2, 2008
April 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy & sensitivity of sentinel lymph node mapping
After confirmed pathological report
Study Arms (2)
1
OTHERIn vivo injection group
2
OTHEREx vivo injection group
Interventions
Eligibility Criteria
You may qualify if:
- Stage I - III colon cancer patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Chung-Ang university Hospital
Seoul, 156-755, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2008
First Posted
April 8, 2008
Study Start
October 1, 2007
Primary Completion
February 1, 2009
Last Updated
April 8, 2008
Record last verified: 2008-04