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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-02-28

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with gastrointestinal cancer scheduled for surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No