UGI HEMORRHAGE AND BARRETTS EPITHELIUM

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My primary career goals related to this award are: 1) to pursue a program of investigator-initiated, hypothesis driven, high quality patient-oriented research in the specialty of digestive diseases, 2) to mentor young clinicians, with little or no research experience, in their career development as patient-oriented researchers, and 3) to continue to mentor and collaborate with other clinical researchers who are beyond the entry level as clinical investigators. Two NIH studies and several new collaborative studies support this research and mentoring proposal. The first NIH Grant, "Studies of UGI Hemorrhage and Endoscopic Hemostasis" evaluates patients with severe upper gastrointestinal bleeding (UGIB) from peptic ulcers, Dieulafoy's lesions, or Mallory Weiss tears. In three consecutive blinded, multicenter randomized trials, our hypothesis is that combination therapy (epinephrine and coagulation) will be significantly better than thermal therapy for initial hemostasis, reduction in early rebleeding rates, and reduction in hospital costs of care. The second NIH Grant, "Prevention of Ulcer Hemorrhage by H.pylori Eradication" is a multicenter, double-blind, randomized comparison of two different medical treatments to prevent recurrence of duodenal ulcer (DU) and gastric ulcer (GU) bleeding. The overall hypotheses to be tested are that 1) eradication of Helicobacter pylori (H. pylori) infection alone will cure most patients of their chronic peptic ulcers and will be substantially equivalent to H.pylori eradication plus full-dose H2RA maintenance in preventing recurrent ulcer hemorrhage and 2) ingestion of aspirin or other non-steroidal anti-inflammatory drugs or recurrence of H.pylori infection will account for all recurrences of ulcer hemorrhage during long-term follow-up. New collaborative studies are also proposed of Barrett's epithelium and prospective trials of variceal and non-variceal hemorrhage. In the mentoring program, new investigators will be trained to perform randomized prospective trials, endoscopic technology assessment studies, and patient-oriented research. This mentoring will be supplemented by didactic courses in biostatistics, seminars in study design, and other instruction in data management, form design for prospective trials, and protocol writing. Emphasis will be placed on planning, designing, and conducting actual prospective randomized studies. This award will enhance the applicant's research productivity and provide skilled mentoring for young investigators, so they can become independent patient-oriented investigators in digestive diseases.