Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Visceral Lymphatic Mapping Project: A Pilot Study

Conditions
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Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with gastrointestinal cancer scheduled for surgery<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 week | 
| Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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