Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
The investigators are testing a device called 4D-ELF. The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this device in this research study.
During your endoscopy ultrasound, the new optic probe will be inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope is getting withdrawn, the light optic probe will be used to examine approximately 5 sections of the small bowel. The probe will be gently placed against the lining of the small bowel and each reading takes less than a second to record.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer|
- 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. [ Time Frame: Completion of Study Procedure (EUS) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Measuring blood flow in the duodenum in patients with pancreatic cancer
Procedure: Endoscopic Ultrasound (EUS)
EUS performed in order to measure blood flow in duodenum for pancreatic cancer
Other Names:Device: EUS/4D-ELF
During the EUS, blood flow will be measured in the duodenum with the 4D-ELF device.
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.