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

Last updated: May 25, 2017
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

N/A

Condition

Gastric Cancer

Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00489515
CDR0000550095
CCCWFU-99B98
CCCWFU-BG99-047
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 115
Study Start date:
February 01, 1999
Estimated Completion Date:
August 31, 2010

Study 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.

Connect with a study center

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157-1096
    United States

    Site Not Available

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