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Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
This study is ongoing, but not recruiting participants.
First Received: June 20, 2007   Last Updated: September 18, 2009   History of Changes
Sponsor: Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00489515
  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 Intervention
Colorectal Cancer
Gallbladder Cancer
Gastric Cancer
Pancreatic Cancer
Small Intestine Cancer
Drug: isosulfan blue
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: conventional surgery
Procedure: lymphadenectomy
Procedure: lymphangiography
Procedure: sentinel lymph node biopsy

Study Type: Interventional
Study Design: Diagnostic
Official Title: Visceral Lymphatic Mapping Project: A Pilot Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety, as determined by the number of adverse events [ Designated as safety issue: Yes ]
  • Feasibility, in terms of the proportion of patients in whom a sentinel lymph node is identified [ Designated as safety issue: No ]
  • Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of sentinel lymph node results vs other nodes [ Designated as safety issue: No ]
  • Comparison of IHC analysis vs standard analysis of the sentinel lymph node [ Designated as safety issue: No ]
  • Value of intraoperative touch prep analysis of sentinel lymph nodes vs standard pathology [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: February 1999
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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
Wake Forest University
Investigators
Study Chair: Edward A. Levine, MD Wake Forest University
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000550095, CCCWFU-99B98, CCCWFU-BG99-047
Study First Received: June 20, 2007
Last Updated: September 18, 2009
ClinicalTrials.gov Identifier: NCT00489515     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Gallbladder Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Ileal Diseases
Rectal Diseases
Duodenal Neoplasms
Neoplasms by Site
Stomach Diseases
Ileal Neoplasms
Jejunal Diseases
Stomach Neoplasms
Biliary Tract Diseases
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Digestive System Neoplasms
Biliary Tract Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Gallbladder Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009