Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489515
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2007-06-20
Brief Title:
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas Colon Stomach Small Intestine or Gallbladder
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Visceral Lymphatic Mapping Project A Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 ie 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 identificationexcision and radical lymphadenectomy Tissue samples are analyzed by IHC for cytokeratins and CEA
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 ie 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 identificationexcision and radical lymphadenectomy Tissue samples are analyzed by IHC for cytokeratins and CEA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-99B98 | None | None | None |
| CCCWFU-BG99-047 | None | None | None |