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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Procedure: Sentinel lymph node procedure
* Procedure: Bone marrow aspiration


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colon cancer<br>Colon cancer patients of all stages | Procedure: Sentinel lymph node procedure<br>* 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.<br>* Other names: Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH;Procedure: Bone marrow aspiration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the extent of upstaging due to the SLN procedure for colon cancer. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node, Lymph node analysis, Bone marrow analysis