The effectiveness of endoscopic therapy for ulcers with non-bleeding visible vessels (NBVV) has not been studied in multiple practice settings throughout the United States. The American Society for Gastrointestinal Endoscopy (ASGE) - Clinical Outcomes Research Initiative (CORI) Project - is a national consortium of gastrointestinal specialists that collects endoscopic data utilizing a computerized endoscopic database to study outcomes in endoscopy. THE PRIMARY AIM OF THIS PILOT/FEASIBILITY STUDY IS TO DEMONSTRATE THE ABILITY OF A NATIONAL CONSORTIUM OF CLINICAL PRACTITIONERS TO COLLECT EFFECTIVENESS DATA COMPARING TWO ENDOSCOPIC TREATMENTS FOR ULCERS WITH NBVV. The efficacy and safety of bipolar coagulation (BP) alone will be compared to bipolar coagulation after injection with epinephrine (BP/E). By incorporating and testing trial data collection this will permit the expansion of data collection in a multicenter study involving practicing physicians in multiple geographic sites in a variety o practice settings. A unique aspect of this study is that it is the first effectiveness and safety study of upper gastrointestinal bleeding (UGIB) performed in multiple practice sites across the United States. Data will be entered at 16 sites and transmitted electronically for analysis. By testing the expanded database structure by implementing this pilot study, the groundwork will be lain for a larger study in which clinical, safety, and economic outcomes will be investigated making use of the CORI data collection infrastructure.
