Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer
Conditions
Keywords
adenocarcinoma of the gallbladder, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, localized gallbladder cancer, small intestine adenocarcinoma, adenocarcinoma of the colon, adenocarcinoma of the pancreas, adenocarcinoma of the stomach
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of 1 of the following sites: * Pancreas * Stomach * Colon * Small bowel * Gallbladder * Patients with highly suspicious pancreatic lesions without definitive tissue biopsy are eligible * No prior uncontrolled visceral malignancy PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical comorbidities that would preclude definitive resection * No known allergies to isosulfan blue PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as determined by the number of adverse events resulting from procedure | 1 week | 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 | 1 week | — |
Countries
United States
Outcome results
None listed