Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.
Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.
|Colonic Neoplasms||Procedure: Sentinel lymph node procedure Procedure: Bone marrow aspiration||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer|
- To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ]
- To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS. [ Time Frame: 1 month, 3 and 5 years after surgery ]
|Study Start Date:||May 2000|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Colon cancer
Colon cancer patients of all stages
Procedure: Sentinel lymph node procedure
After careful mobilization of the affected colon segment, isosulfan blue 1% is injected in vivo into the subserosa circumferentially around the tumor. Lymph nodes in the mesentery staining blue within the first minutes are marked as SLN. The procedure is followed by a resection of the affected colon segment with standard lymphadenectomy.
Other Name: Lymphazurin 1%, Ben Venue Labs Inc., Bedford OHProcedure: Bone marrow aspiration
Prior to surgery, bone marrow is aspirated from both iliac crests. Bone marrow aspirates are analyzed for the presence of occult metastatic colon cancer cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826579
|Carsten T. Viehl, MD|
|Basel, Switzerland, 4031|
|Urban Laffer, MD|
|Biel, Switzerland, 2501|
|Markus Zuber, MD|
|Olten, Switzerland, 4600|
|Principal Investigator:||Carsten T. Viehl, MD||aktuell: Spitalzentrum Biel-Bienne|
|Principal Investigator:||Markus Zuber, MD||Kantonsspital Olten|