Optimizing the role of ERCP in evaluating indeterminate bile duct strictures

优化 ERCP 在评估不确定性胆管狭窄中的作用

• 批准号: 8434842
• 负责人: Gregory A Cote
• 金额: $ 16.92万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8434842
• 关键词: Accounting; Award; Benign; Bile duct carcinoma; Biliary; Biometry; Biopsy; Cellularity; Cessation of life; Characteristics; Classification; Clinical; Clinical Investigator; Clinical Medicine; Clinical Research; Clinical Trials; Clinical Trials Design; Cohort Studies; Cytogenetics; Cytology; Data; Databases; Development; Diagnosis; Diagnostic; Diagnostic Sensitivity; Diagnostic tests; Endoscopic Retrograde Cholangiopancreatography; Endoscopy; Enrollment; Environment; Epidemiology; Epithelial; Etiology; Evaluation; Extramural Activities; Feasibility Studies; Fee Schedules; Fluorescent in Situ Hybridization; Funding; Gastroenterology; Health Care Costs; Health system; Hepatology; Indiana; Knowledge; Life Expectancy; Link; Malignant - descriptor; Malignant Neoplasms; Measures; Medical; Medicare; Mentors; Mentorship; Modality; Morbidity - disease rate; Obstruction; Obstructive Jaundice; Outcomes Research; Pancreatic duct; Patient Care; Patients; Performance; Pilot Projects; Provider; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Registries; Research; Research Infrastructure; Research Personnel; Resources; Role; Sampling; Science; Series; Specificity; Specimen; Structure; Testing; Time; Tissue Sample; Tissues; Training; Ultrasonography; United States; United States National Institutes of Health; Universities; base; bile stricture; cancer cell; cancer diagnosis; career; career development; clinical practice; cost; cost effective; cost effectiveness; economic outcome; epidemiology study; experience; health economics; improved; indexing; interest; medical schools; multimodality; patient oriented; patient oriented research; primary sclerosing cholangitis; professor; prospective; skill acquisition; tool

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.

描述（由申请人提供）：候选人（Gregory Cote博士）是印第安纳州大学医学院胃肠病学和肝病学系临床医学助理教授。他是一名临床研究员和高级胰胆内镜医生，他渴望成为一名独立的临床研究者，在胰胆内镜的患者导向的结局研究中获得持续的外部资金，特别强调成本效益/卫生经济学。PI正在申请K23，以获得受保护的学术时间，以获得先进的流行病学，卫生经济学和大型电子数据库研究的技能。除了一个多样化的导师团队和专家沿着完成结构化的课程，由K23提供的保护时间将使他获得经验，完成指导临床研究使用大型电子数据库和完成试点，随机临床试验。在拟议的职业发展期间，他的研究重点是研究各种基于ERCP的诊断策略的流行病学，疗效和成本，以评估胆管狭窄。 中 在2002年关于ERCP的科学现状声明中，NIH确定了ERCP的主要局限性是其在胆道梗阻/狭窄情况下检测恶性肿瘤的敏感性较差。因此，对胆道梗阻患者最具成本效益的诊断方法是未知的。拟议的研究将评价用于表征不确定胆管狭窄的多种基于ERCP的模式的增量产率，并定义当前临床实践中胆管狭窄诊断检测的流行病学。虽然众所周知，区分不确定的胆管狭窄的恶性和良性病因是困难的，但是量化该问题的程度并识别与更强烈的诊断测试相关联的患者和提供者特征的数据有限（即，更昂贵的诊断评估）。由于胰腺癌和胆管癌每年在美国造成超过50，000例死亡，因此迫切需要改善我们对这些患者的术前评估和管理。PI已经组建了一个由胰胆研究（谢尔曼）和流行病学/卫生经济学（阿克曼）专家组成的主要导师团队。这些都是由科学顾问在流行病学和数据库研究（罗森曼），生物统计学（惠）和细胞遗传学（万斯），以及二级导师与专业知识的职业发展和胃肠道流行病学（帝国）和胰胆内镜研究（雷曼）的支持。PI已经制定了一个强有力的职业计划，并且在提供受保护的时间，基础设施和资源方面对候选人做出了强有力的机构承诺。印第安纳州大学医学院的初级研究人员培训和开展临床研究的环境非常出色。导师团队，职业发展战略，拟议的研究和环境制定了发展申请人成为独立临床研究者的蓝图。