Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue, may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and find out how far the disease has spread.
PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach, small intestine, or gallbladder.
Small Intestine Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Visceral Lymphatic Mapping Project: A Pilot Study|
- Safety, as determined by the number of adverse events resulting from procedure [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
- Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Time Frame: 1 week ] [ Designated as safety issue: No ]
|Study Start Date:||February 1999|
|Study Completion Date:||August 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|patients with gastrointestinal cancer scheduled for surgery|
- Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or gallbladder.
- 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 patients.
- 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 these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489515
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Edward A. Levine, MD||Wake Forest University Health Sciences|