Optimizing the role of ERCP in evaluating indeterminate bile duct strictures

描述（由申请人提供）：候选人（Gregory Cote博士）是印第安纳大学医学院胃肠病学和肝脏病学临床医学助理教授。他是一名临床研究员和高级胰胆管内窥镜专家，他渴望成为一名独立的临床研究者，在胰胆管内窥镜以患者为导向的结果研究中获得持续的校外资助，特别强调成本效益/健康经济学。PI正在申请K23，以获得受保护的学术时间，以获得高级流行病学、卫生经济学和大型电子数据库研究方面的技能。除了多样化的专家导师团队以及完成结构化的课程外，K23提供的保护时间将使他能够获得使用大型电子数据库完成指导临床研究和完成试点随机临床试验的经验。在拟建的职业发展期内，他的研究重点是研究各种基于ercp的胆管狭窄诊断策略的流行病学、疗效和成本。在一个

DESCRIPTION (provided by applicant): The candidate (Dr. Gregory Cote) is an Assistant Professor of Clinical Medicine in the Division of Gastroenterology and Hepatology at Indiana University School of Medicine. He is a clinical researcher and advanced pancreatobiliary endoscopist who aspires to become an independent clinical investigator with sustained extramural funding in patient-oriented outcomes research in pancreatobiliary endoscopy, with a particular emphasis on cost effectiveness/health economics. The PI is applying for a K23 to obtain protected academic time for the acquisition of skills in advanced epidemiology, health economics and studies of large electronic databases. In addition to a diverse and expert team of mentors along with completing structured coursework, the protected time offered by a K23 will allow him to gain experience in completing mentoring clinical investigations using large electronic databases and completing a pilot, randomized clinical trial. The focus of his research during the proposed career development period is in studying the epidemiology, efficacy and costs of various ERCP-based diagnostic strategies for the evaluation of bile duct strictures. In a 2002 State-of-the-Science statement on ERCP, the NIH identified a principal limitation of ERCP being its poor sensitivity for detecting malignancy in the setting of a biliary obstruction/strictue. As a result, the most cost effective diagnostic approach to patients with biliary obstruction is unknown. The proposed studies will evaluate the incremental yield of multiple ERCP-based modalities for characterizing indeterminate bile duct strictures and define the epidemiology of diagnostic testing for bile duct strictures in current clinical practice. While it is notoriously dfficult to differentiate malignant and benign etiologies for indeterminate bile duct strictures, there are limited data quantifying the magnitude of this problem and identifying patient and provider characteristics that are associated with more intense diagnostic testing (i.e., a more costly diagnostic evaluation). Since pancreatic and bile duct cancer account for > 50,000 deaths in the United States each year, there is a critical need to improve our preoperative evaluation and management of these patients. The PI has compiled a team of primary mentors from experts in pancreatobiliary research (Sherman) and epidemiology/health economics (Ackermann). These are supported by scientific advisors in epidemiology and database research (Rosenman), biostatistics (Hui) and cytogenetics (Vance), as well as secondary mentors with expertise in career development and GI epidemiology (Imperiale) and pancreatobiliary endoscopy research (Lehman). The PI has assembled a strong career plan and there is a robust institutional commitment to the candidate in terms of offering protected time, infrastructure, and resources. The environment for training and conducting clinical research by junior investigators at Indiana University School of Medicine is outstanding. The mentorship team, career development strategy, proposed research and environment formulate the blueprint for developing the applicant into an independent clinical investigator.