Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00826579|
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Procedure: Sentinel lymph node procedure Procedure: Bone marrow aspiration||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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 OH
Procedure: 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|