Trial Information
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Inclusion Criteria:
- Colon cancer at any stage diagnosed histologically or high degree of suspicion for
colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy.
The diagnosis of cancer must be certain in the definitive histology.
- Possibility of transabdominal injection of the dye (cancers below the peritoneal
reflection in which the injection of dye must be carried out through rectoscopy, are
therefore excluded).
- Patient's informed consent
Exclusion Criteria:
- Prior intrabdominal tumor surgery
- Other preexisting malignancies
- Hypersensitivity/allergy to dye (isosulfan blue)
- Pregnancy
- Breast-feeding
- No patient's informed consent
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To assess the extent of upstaging due to the SLN procedure for colon cancer.
Outcome Time Frame:
1 month
Safety Issue:
No
Principal Investigator
Carsten T. Viehl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Basel, Switzerland
Authority:
Switzerland: Ethikkommission
Study ID:
Rhein4031
NCT ID:
NCT00826579
Start Date:
May 2000
Completion Date:
December 2011
Related Keywords:
- Colonic Neoplasms
- Sentinel lymph node
- Lymph node analysis
- Bone marrow analysis
- Neoplasms
- Colonic Neoplasms