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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-99B98 | |||
| CCCWFU-BG99-047 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with gastrointestinal cancer scheduled for surgery |
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| 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of 1 of the following sites:
Patients with highly suspicious pancreatic lesions without definitive tissue biopsy are eligible
No prior uncontrolled visceral malignancy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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patients with gastrointestinal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Edward A. Levine, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12455783 | Result | Hundley JC, Shen P, Shiver SA, Geisinger KR, Levine EA. Lymphatic mapping for gastric adenocarcinoma. Am Surg. 2002 Nov;68(11):931-5. | |
| 12850683 | Result | Levine EA, Shen P, Shiver SA, Waters G, Brant A, Geisenger KR. Intraoperative imprint cytology for evaluation of sentinel lymph nodes from visceral malignancies. J Gastrointest Surg. 2003 Jul-Aug;7(5):687-91. doi: 10.1016/s1091-255x(03)00069-6. |
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| 11261621 | Result | Waters GS, Geisinger KR, Garske DD, Loggie BW, Levine EA. Sentinel lymph node mapping for carcinoma of the colon: a pilot study. Am Surg. 2000 Oct;66(10):943-5; discussion 945-6. |
| 16875082 | Result | Thomas KA, Lechner J, Shen P, Waters GS, Geisinger KR, Levine EA. Use of sentinel node mapping for cancer of the colon: 'to map or not to map". Am Surg. 2006 Jul;72(7):606-11; discussion 611-2. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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