Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
The overall goal of this study is to test a technique that in the future may allow
endoscopic detection of pancreatic neoplasia. The study is a single group, prospective,
open label pilot study designed to assess the feasibility and efficacy of 4D-ELF in
detecting EIBS in peri-ampullary duodenal mucosa in pancreatic cancer patients compared to
control patients. The expected duration of subject participation, and a description of the
sequence and duration of all trial periods, including follow-up is complete after the
initial evaluation.
Inclusion Criteria:
- Age 18 years or older.
- Informed written consent.
- Patient scheduled for previously planned EUS or ERCP.
- Patients with known adenocarcinoma of the pancreas.
Exclusion Criteria:
- Presence of conditions not allowing biopsy or FNA if clinically indicated (e.g.
coagulation disorder).
- Significant family history of pancreatic cancer.
- Patients with other tumors of the pancreas or duodenum (i.e neuroendocrine tumors,
carcinoid, GIST, known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis,
etc)).
- Patient with premalignant lesions (duodenal adenoma, IPMN).
- Active duodenitis/ulcer from any cause (peptic, H pylori etc).
- Patients with known chronic pancreatitis will be excluded from study group (not
control group however).
- Know pregnancy or sexually active females of childbearing age who are not practicing
an accepted form of birth control.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To investigate whether EIBS measurements from pancreatic cancer will be elevated when measured in the peri-ampullary duodenal mucosa, in comparison to the same measures from control patients undergoing upper endoscopy without know pancreatic cancer.
Outcome Time Frame:
Completion of Study Procedure (EUS)
Safety Issue:
No
Principal Investigator
Michael B. Wallace, MD MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
09-002596
NCT ID:
NCT01015820
Start Date:
June 2010
Completion Date:
October 2012
Related Keywords:
- Pancreatic Cancer
- Pancreatic Cancer
- Duodenum
- Increase Blood Flow
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Florida | Jacksonville, Florida 32224 |
