Forbes Nauzer, Koury Hannah F, Bass Sydney, Cole Martin, Mohamed Rachid, Turbide Christian, Gonzalez-Moreno Emmanuel, Kayal Ahmed, Chau Millie, Lethebe B Cord, Hilsden Robert J, Heitman Steven J
Department of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
J Can Assoc Gastroenterol. 2020 Feb 28;4(2):78-83. doi: 10.1093/jcag/gwaa007. eCollection 2021 Apr.
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure in the management of pancreatic and biliary disease. While its role is firmly established, further well-designed prospective ERCP research is required, as a large portion of previous work has employed retrospective or administrative methodologies, both prone to potential biases. The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multicentre registry.
The study population consisted of consecutive adult ERCP patients from September 2018 to September 2019. Informed consent was acquired for each patient. All relevant preprocedural, procedural, peri-procedural and postprocedural data were captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes were ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure.
Five endoscopists performed 895 ERCP procedures, 90.1% of which were deemed successful. Suspected choledocholithiasis was the most common indication for ERCP, followed by suspected or confirmed stricture(s), at 61.0% and 29.5%, respectively. 61.0% of procedures were performed on ERCP-naive patients. Post-ERCP pancreatitis occurred following 4.9% of procedures, with clinically significant bleeding or perforation occurring following 1.8% and 0.1% of procedures, respectively.
Through 12 months, CReATE captured 895 procedures prospectively, with each entry containing over 300 data fields. Active expansion to additional tertiary centres is underway, and this will enhance the existing data pool. CReATE has the potential to improve multiple facets of ERCP, including training, optimal procedural techniques, mitigation of adverse events and personalized patient care.
内镜逆行胰胆管造影术（ERCP）是胰腺和胆道疾病管理中的一项重要操作。虽然其作用已得到明确确立，但仍需要进一步设计良好的前瞻性ERCP研究，因为之前的大部分工作都采用了回顾性或管理性方法，这两种方法都容易产生潜在偏差。卡尔加里高级治疗性内镜注册中心（CReATE）的目标是成为一个高保真的前瞻性多中心注册中心。
研究人群包括2018年9月至2019年9月连续的成年ERCP患者。为每位患者获取了知情同意书。所有相关的术前、术中、围手术期和术后数据由一名全职第三方研究助理通过直接观察手术实时记录。在索引手术30天后，通过全面的病历审查和患者电话访谈确定结果。
5名内镜医师进行了895例ERCP手术，其中90.1%被认为成功。疑似胆总管结石是ERCP最常见的适应证，其次是疑似或确诊的狭窄，分别为61.0%和29.5%。61.0%的手术是在初次接受ERCP的患者身上进行的。4.9%的手术后发生了ERCP后胰腺炎，分别有1.8%和0.1%的手术发生了具有临床意义的出血或穿孔。
在12个月的时间里，CReATE前瞻性地记录了895例手术，每个条目包含300多个数据字段。目前正在积极向其他三级中心扩展，这将增加现有的数据库。CReATE有潜力改善ERCP的多个方面，包括培训、最佳手术技术、减少不良事件和个性化患者护理。
