Colon Cancer Clinical Trial
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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