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: 8280031
• 负责人: Gregory A Cote
• 金额: $ 17.63万
• 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/8280031
• 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. 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.

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病学部的临床医学助理教授。他是一名临床研究员和高级胰胆内窥镜医师，渴望成为一名独立的临床研究者，在胰胆内窥镜以患者为导向的结果研究方面获得持续的外部资金，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，以获取高级流行病学、卫生经济学和大型电子数据库研究方面的技能。除了多元化的专家导师团队以及完成结构化课程之外，K23 提供的受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。在拟议的职业发展期间，他的研究重点是研究用于评估胆管狭窄的各种基于 ERCP 的诊断策略的流行病学、功效和成本。 在一个 2002 年关于 ERCP 的科学现状声明中，NIH 指出 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尚不清楚。拟议的研究将评估多种基于 ERCP 的模式用于表征不确定胆管狭窄的增量产量，并定义当前临床实践中胆管狭窄诊断测试的流行病学。虽然众所周知，区分不确定性胆管狭窄的恶性和良性病因非常困难，但量化该问题严重程度并确定与更严格的诊断测试（即更昂贵的诊断评估）相关的患者和提供者特征的数据有限。 。由于胰腺癌和胆管癌每年导致美国超过 50,000 人死亡，因此迫切需要改进对这些患者的术前评估和管理。 PI 组建了一个由胰胆研究 (Sherman) 和流行病学/卫生经济学 (Ackermann) 专家组成的主要导师团队。这些工作得到了流行病学和数据库研究 (Rosenman)、生物统计学 (Hui) 和细胞遗传学 (Vance) 方面的科学顾问以及具有职业发展和胃肠道流行病学 (Imperiale) 和胰胆内窥镜研究 (Lehman) 方面专业知识的二级导师的支持。 PI 制定了强有力的职业计划，并且在提供受保护的时间、基础设施和资源方面向候选人做出了强有力的制度承诺。印第安纳大学医学院为初级研究人员提供培训和开展临床研究的环境非常出色。导师团队、职业发展策略、拟定研究和环境制定了将申请人培养成独立临床研究者的蓝图。 公共健康相关性：本申请由印第安纳大学代表 Gregory Cote 博士提交，Gregory Cote 博士是一名从事胰胆内窥镜检查领域以患者为导向的研究的初级研究员。在此申请中，PI 提出了一系列与不确定性胆道狭窄相关的假设驱动的临床研究，这将作为其职业发展的工具 在有能力的指导小组和优秀的机构支持和资源的支持下。 PI 提议进行以下研究：1) 定义胆管狭窄的流行病学，特别关注与更多诊断测试相关的因素，例如狭窄的病因以及患者和提供者/设施的特征；2) 衡量绩效基于 ERCP 策略的特点，以确定不确定性胆管狭窄患者的最佳诊断方法。