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

Colorectal Cancer Clinical Trial

Official title:

Visceral Lymphatic Mapping Project: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489515
• Other study ID #: CDR0000550095
• Secondary ID: CCCWFU-99B98CCCW
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: May 25, 2017
• Start date: February 1999
• Est. completion date: August 2010

Study information

• Verified date: February 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Intestinal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hundley JC, Shen P, Shiver SA, Geisinger KR, Levine EA. Lymphatic mapping for gastric adenocarcinoma. Am Surg. 2002 Nov;68(11):931-5. — View Citation

Levine EA, Shen P, Shiver SA, Waters G, Brant A, Geisenger KR. Intraoperative imprint cytology for evaluation of sentinel lymph nodes from visceral malignancies. J Gastrointest Surg. 2003 Jul-Aug;7(5):687-91. — View Citation

Thomas KA, Lechner J, Shen P, Waters GS, Geisinger KR, Levine EA. Use of sentinel node mapping for cancer of the colon: 'to map or not to map". Am Surg. 2006 Jul;72(7):606-11; discussion 611-2. — View Citation

Waters GS, Geisinger KR, Garske DD, Loggie BW, Levine EA. Sentinel lymph node mapping for carcinoma of the colon: a pilot study. Am Surg. 2000 Oct;66(10):943-5; discussion 945-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, as determined by the number of adverse events resulting from procedure	Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure	1 week
Primary	Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor		1 week