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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00489515

Collaborator

National Cancer Institute (NCI) (NIH)

115

Enrollment

Location

138

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Visceral Lymphatic Mapping Project: A Pilot Study

Study Start Date :

Feb 1, 1999

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
patients with gastrointestinal cancer scheduled for surgery

Outcome Measures

Primary Outcome Measures

Safety, as determined by the number of adverse events resulting from procedure [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 [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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