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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new optic probe will be inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope is getting withdrawn, the light optic probe will be used to examine approximately 5 sections of the small bowel.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.
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.
Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Endoscopic Ultrasound (EUS), EUS/4D-ELF
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:17:55-0400
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Fiberoptic endoscopy designed for duodenal observation and cannulation of VATER'S AMPULLA, in order to visualize the pancreatic and biliary duct system by retrograde injection of contrast media. Endoscopic (Vater) papillotomy (SPHINCTEROTOMY, ENDOSCOPIC) may be performed during this procedure.
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Star-shaped, myofibroblast-like cells located in the periacinar, perivascular, and periductal regions of the EXOCRINE PANCREAS. They play a key role in the pathobiology of FIBROSIS; PANCREATITIS; and PANCREATIC CANCER.
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
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