Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
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Purpose
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.
| Condition |
|---|
|
Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Visceral Lymphatic Mapping Project: A Pilot Study |
- Safety, as determined by the number of adverse events resulting from procedure [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
- Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Enrollment: | 115 |
| Study Start Date: | February 1999 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| patients with gastrointestinal cancer scheduled for surgery |
Detailed 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with gastrointestinal cancer
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Study Chair: | Edward A. Levine, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00489515 History of Changes |
| Other Study ID Numbers: | CDR0000550095, CCCWFU-99B98, CCCWFU-BG99-047 |
| Study First Received: | June 20, 2007 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Gallbladder Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Duodenal Diseases Ileal Diseases Jejunal Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases |
ClinicalTrials.gov processed this record on May 16, 2013