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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00489515
First received: June 20, 2007
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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
Colorectal Cancer
Gallbladder Cancer
Gastric Cancer
Pancreatic Cancer
Small Intestine Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Visceral Lymphatic Mapping Project: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Safety, as determined by the number of adverse events resulting from procedure [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: February 1999
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with gastrointestinal cancer scheduled for surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489515

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Edward A. Levine, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00489515     History of Changes
Other Study ID Numbers: CDR0000550095, CCCWFU-99B98, CCCWFU-BG99-047
Study First Received: June 20, 2007
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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
Stomach Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal 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
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Duodenal Diseases
Ileal Diseases
Jejunal Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on April 14, 2014