Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
NCT ID: NCT00826579
Last Updated: 2015-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
192 participants
INTERVENTIONAL
2000-05-31
2009-01-31
Brief Summary
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Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Colon cancer
Colon cancer patients of all stages
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Other preexisting malignancies
* Hypersensitivity/allergy to dye (isosulfan blue)
* Pregnancy
* Breast-feeding
* No patient's informed consent
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Carsten T. Viehl, MD
Role: PRINCIPAL_INVESTIGATOR
aktuell: Spitalzentrum Biel-Bienne
Markus Zuber, MD
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Olten
Locations
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Carsten T. Viehl, MD
Basel, , Switzerland
Urban Laffer, MD
Biel, , Switzerland
Markus Zuber, MD
Olten, , Switzerland
Countries
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References
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Weixler B, Viehl CT, Warschkow R, Guller U, Ramser M, Sauter G, Zuber M. Comparative Analysis of Tumor Cell Dissemination to the Sentinel Lymph Nodes and to the Bone Marrow in Patients With Nonmetastasized Colon Cancer: A Prospective Multicenter Study. JAMA Surg. 2017 Oct 1;152(10):912-920. doi: 10.1001/jamasurg.2017.1514.
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.
Other Identifiers
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Rhein4031
Identifier Type: -
Identifier Source: org_study_id
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