Trials / Completed
CompletedNCT00489515
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
Visceral Lymphatic Mapping Project: A Pilot Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 115 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Timeline
- Start date
- 1999-02-01
- Primary completion
- 2009-06-01
- Completion
- 2010-08-01
- First posted
- 2007-06-21
- Last updated
- 2017-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00489515. Inclusion in this directory is not an endorsement.