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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland Identifier:
First received: January 13, 2009
Last updated: March 11, 2015
Last verified: March 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 Intervention Phase
Colonic Neoplasms Procedure: Sentinel lymph node procedure Procedure: Bone marrow aspiration Phase 1 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • To assess the extent of upstaging due to the SLN procedure for colon cancer. [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 192
Study Start Date: May 2000
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00826579

Carsten T. Viehl, MD
Basel, Switzerland, 4031
Urban Laffer, MD
Biel, Switzerland, 2501
Markus Zuber, MD
Olten, Switzerland, 4600
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Carsten T. Viehl, MD aktuell: Spitalzentrum Biel-Bienne
Principal Investigator: Markus Zuber, MD Kantonsspital Olten
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00826579     History of Changes
Other Study ID Numbers: Rhein4031
Study First Received: January 13, 2009
Last Updated: March 11, 2015

Keywords provided by University Hospital, Basel, Switzerland:
Sentinel lymph node
Lymph node analysis
Bone marrow analysis

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases processed this record on September 21, 2017