Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
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|ClinicalTrials.gov Identifier: NCT00489515|
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : May 30, 2017
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 or disease|
|Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer|
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||Visceral Lymphatic Mapping Project: A Pilot Study|
|Study Start Date :||February 1999|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2010|
|patients with gastrointestinal cancer scheduled for surgery|
- Safety, as determined by the number of adverse events resulting from procedure [ Time Frame: 1 week ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489515
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Edward A. Levine, MD||Wake Forest University Health Sciences|