Optimizing the role of ERCP in evaluating indeterminate bile duct strictures

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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. PUBLIC HEALTH RELEVANCE: This application is submitted by Indiana University on behalf of Dr. Gregory Cote, a junior investigator pursuing patient-oriented research in pancreatobiliary endoscopy. In this application, the PI proposes a series hypothesis-driven clinical investigations related to indeterminate biliary strictures which will serve as vehicles for his career development with support of a capable mentorship panel and excellent institutional support and resources. The PI proposes the following studies to: 1) define the epidemiology of bile duct strictures, specifically focusing on the factors associated with more diagnostic testing such as the etiology of the stricture as well as patient and provider/facility characteristics and 2) measure the performance characteristics of ERCP-based strategies to determine the optimal diagnostic approach to patients with indeterminate bile duct strictures.