Visceral Lymphatic Mapping Project: A Pilot Study
- Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue
in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or
- Evaluate the ability of surgically defined sentinel lymph nodes to predict whether
other lymph nodes in the basin are involved with the tumor in these patients.
- Compare the results obtained from the sentinel lymph node (i.e., positive or negative
for metastatic disease) with the results obtained from the other nodes in these
- Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes
in these patients.
- Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in
OUTLINE: This is a pilot study.
During surgical resection of the primary tumor, patients receive isosulfan blue
subcutaneously 5 minutes before undergoing sentinel lymph node identification/excision and
radical lymphadenectomy. Tissue samples are analyzed by IHC for cytokeratins and CEA.
Observational Model: Cohort, Time Perspective: Prospective
Safety, as determined by the number of adverse events resulting from procedure
Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
Edward A. Levine, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|