Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00826579

Purpose

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 I Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Iso-sulfan blue

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2000
Estimated Study Completion Date:	December 2011
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Colon cancer: Experimental 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. 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.

Arms

Assigned Interventions

Colon cancer: Experimental

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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826579

Locations

Switzerland
Carsten T. Viehl, MD
Basel, Switzerland, 4031
Markus Zuber, MD
Olten, Switzerland, 4600
Urban Laffer, MD
Biel, Switzerland, 2501

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:	Carsten T. Viehl, MD	University Hospital, Basel, Switzerland
Principal Investigator:	Markus Zuber, MD	Kantonsspital Olten, Switzerland

More Information

No publications provided

Responsible Party:	University Hospital, Basel, Switzerland ( Carsten T. Viehl, MD )
Study ID Numbers:	Rhein4031
Study First Received:	January 13, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00826579 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

Sentinel lymph node
Lymph node analysis
Bone marrow analysis

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009