Clinical trial NCT00826579: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Official title: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colonic Neoplasms
Keywords: Sentinel lymph node
Lymph node analysis
Bone marrow analysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: To assess the extent of upstaging due to the SLN procedure for colon cancer.
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 1 month, 3 and 5 years after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Carsten T. Viehl, MD
city: Biel
country: Switzerland
facility: Urban Laffer, MD
city: Olten
country: Switzerland
facility: Markus Zuber, MD
Study officials:
affiliation: aktuell: Spitalzentrum Biel-Bienne
name: Carsten T. Viehl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Olten
name: Markus Zuber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.