Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University Hospital, Basel, Switzerland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00826579
First received: January 13, 2009
Last updated: January 20, 2009
Last verified: January 2009

January 13, 2009
January 20, 2009
May 2000
January 2009   (final data collection date for primary outcome measure)
To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00826579 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Colonic Neoplasms
  • 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.
Experimental: Colon cancer
Colon cancer patients of all stages
Interventions:
  • Procedure: Sentinel lymph node procedure
  • Procedure: Bone marrow aspiration
Viehl CT, Guller U, Langer I, Laffer U, Oertli D, Zuber M. Factors influencing the success of in vivo sentinel lymph node procedure in colon cancer patients: Swiss prospective, multicenter study sentinel lymph node procedure in colon cancer. World J Surg. 2013 Apr;37(4):873-7. doi: 10.1007/s00268-013-1910-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2011
January 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00826579
Rhein4031
No
Carsten T. Viehl, MD, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Carsten T. Viehl, MD University Hospital, Basel, Switzerland
Principal Investigator: Markus Zuber, MD Kantonsspital Olten
University Hospital, Basel, Switzerland
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP