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.
- Age 18 years or older.
- Informed written consent.
- Patient scheduled for previously planned EUS or ERCP.
- Patients with known adenocarcinoma of the pancreas.
- 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.
We 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new optic probe will be inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope is getting withdrawn, the light optic probe will be used to examine approximately 5 sections of the small bowel.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.
Until the completion of the Endoscopic Ultrasound. Approximately 1 hour.Principal Investigator - Michael B. Wallace, M.D.
Last updated: 11/06/2012
NCT ID: NCT01015820