Visceral Lymphatic Mapping Project: A Pilot Study
18 Years
N/A
Both
Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer
Trial Information
Visceral Lymphatic Mapping Project: A Pilot Study
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety, as determined by the number of adverse events resulting from procedure
Outcome Description:
Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
Outcome Time Frame:
1 week
Safety Issue:
Yes
Principal Investigator
Edward A. Levine, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000550095
NCT ID:
NCT00489515
Start Date:
February 1999
Completion Date:
August 2010
Related Keywords:
- Colorectal Cancer
- Gallbladder Cancer
- Gastric Cancer
- Pancreatic Cancer
- Small Intestine Cancer
- 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
- Colorectal Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Gallbladder Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
