Colonic Neoplasms
Conditions
Keywords
Sentinel lymph node, Lymph node analysis, Bone marrow analysis
Brief summary
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.
Interventions
PROCEDURESentinel 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.
PROCEDUREBone 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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the extent of upstaging due to the SLN procedure for colon cancer. | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 1 month, 3 and 5 years after surgery |
Countries
Switzerland
Outcome results
None listed