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.
Primary Outcome Measures:
- Safety, as determined by the number of adverse events [ Designated as safety issue: Yes ]
- Feasibility, in terms of the proportion of patients in whom a sentinel lymph node is identified [ Designated as safety issue: No ]
- Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of sentinel lymph node results vs other nodes [ Designated as safety issue: No ]
- Comparison of IHC analysis vs standard analysis of the sentinel lymph node [ Designated as safety issue: No ]
- Value of intraoperative touch prep analysis of sentinel lymph nodes vs standard pathology [ Designated as safety issue: No ]
| Estimated Enrollment: |
125 |
| Study Start Date: |
February 1999 |
| Estimated Primary Completion Date: |
December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Purpose
