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

Wake Forest University (WFU)

Status: Completed

Conditions: Gallbladder Cancer; Gastric Cancer; Small Intestine Cancer; Pancreatic Cancer; Colorectal Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00489515

CCCWFU-99B98

CDR0000550095

CCCWFU-BG99-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

115 participants in 1 patient group

patients with gastrointestinal cancer scheduled for surgery