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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
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 : February 1999
Primary Completion Date : June 2009
Study Completion Date : August 2010


Groups and Cohorts

Group/Cohort
patients with gastrointestinal cancer scheduled for surgery


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Time Frame: 1 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with gastrointestinal cancer
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Edward A. Levine, MD Wake Forest University Health Sciences
More Information

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00489515     History of Changes
Other Study ID Numbers: CDR0000550095
CCCWFU-99B98
CCCWFU-BG99-047
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
adenocarcinoma of the gallbladder
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
localized gallbladder cancer
small intestine adenocarcinoma
adenocarcinoma of the colon
adenocarcinoma of the pancreas
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Gallbladder Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases