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



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:February 1999
End Date:August 2010

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Visceral Lymphatic Mapping Project: A Pilot Study

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

- 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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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mi
from
Winston-Salem, NC
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