Know Cancer

forgot password

Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer

18 Years
Not Enrolling
Pancreatic Cancer

Thank you

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,

- 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:


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:


Principal Investigator

Michael B. Wallace, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

October 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Duodenum
  • Increase Blood Flow
  • Pancreatic Neoplasms



Mayo Clinic FloridaJacksonville, Florida  32224