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OpenTrials
Completed

NCT Number: NCT00489515

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Visceral Lymphatic Mapping Project: A Pilot Study

Important dates

Study start
1999
Primary completion
2009
Study completion
2010
First posted
Jun 21, 2007
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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