Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Positive or negative diagnosis of choledocholithiasis
研究概览
简要总结
Choledocholithiasis (stone(s) in the common bile duct) is common. Untreated or missed, choledocholithiasis has high morbidity and mortality. Endoscopic retrograde cholangio-pancreatography (ERCP) is recognized as the first-line modality for management. While effective, ERCP is associated with adverse events. Thus, the selection of patients for ERCP should be accompanied by a high pre-test suspicion of choledocholithiasis.
Choledocholithiasis is suspected based on clinical, biochemical and radiographic findings. The most relied-upon strategy for risk stratification of choledocholithiasis is based on guidelines from The American Society for Gastrointestinal Endoscopy (ASGE). In it, clinical predictors are defined as "very strong", "strong" or "moderate", and the presence of one or more of these is meant to suggest "high" or "intermediate" probability of choledocholithiasis.
A knowledge gap exists in the performance characteristics of intermediate-probability criteria, where overall accuracy is <50% from limited data. Patients in this group are recommended to a) undergo endoscopic ultrasound (EUS) or magnetic resonance cholangio-pancreatography (MRCP), b) undergo cholecystectomy with intra-operative cholangiography (IOC), or c) proceed directly to ERCP. At centres where EUS and MRCP are readily available, these are preferred options, as they are least invasive and sensitive; however, they are often unavailable. Thus, in clinical practice, a high proportion of intermediate-risk patients ultimately proceed directly to ERCP, where likelihood of benefit is only moderate, while procedural risk remains.
The role of liver enzyme changes has not been evaluated; however, dynamic changes may offer another method for evaluating patients at intermediate risk of CBD stones that is safe and available. Incorporation of dynamic liver enzymes may improve the test-performance characteristics of the existing framework.
详细描述
There are two planned phases for this proposed study. The first will be a retrospective phase aimed at assessing the test performance characteristics of the current guideline-based criteria, and subsequently with developing a novel with the incorporation of dynamic liver enzyme changes into the intermediate-probability CBD stone management algorithm. In the second phase, we will evaluate and prospectively validate the proposed model.
Phase 1 - Retrospective Evaluation
This will be a retrospective study of patients evaluated for suspected choledocholithiasis. Given the nature of our tertiary care facility as outlined above, this will constitute a population-based study of a sample of 1,000 patients from 2012-2017 who underwent evaluation for choledocholithiasis. The selection of 2012 as the start of our study period is based on an appropriate time lag from publication to widespread clinical adoption of the ASGE guidelines, which were published in 2010.
An institutional endoscopy database and reporting platform (Endopro, Pentax) has been used in Calgary since 2000, and it is estimated that well over 95% of all ERCP and EUS procedures have been reported using Endopro since its implementation. We will employ several strategies to capture patients. We will initially search our Endopro database for all ERCPs and EUS exams performed where the indication was "suspected choledocholithiasis" of any probability. This broad search strategy will identify all possible choledocholithiasis cases. Potential cases will then be grouped by patient name and ordered by data.
Once the potential cases are gathered, and the appropriate sample of 1,000 extracted, a manual review of each of the endoscopy reports will be performed, in addition to a review of the patients' medical records through Sunrise Clinical Manager, by one of two independent medical reviewers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected choledocholithiasis, regardless of probability
- •age 18 years old or older
- •able to give informed consent to involvement (in the prospective validation phase).
排除标准
- •Unable or unwilling to provide informed consent;
- •age < 18 years;
- •suspected or proven cholangitis;
- •previous ERCP with sphincterotomy;
- •prior diagnosis or management of choledocholithiasis;
- •outpatient status;
- •out-of-province status (prohibiting full medical record access).
结局指标
主要结局
Positive or negative diagnosis of choledocholithiasis
时间窗: immediate
Retrospective analysis will be employed to determine the individual and joint test performance characteristics of the parameters in the ASGE guideline, and to determine the (lone and additional) test characteristics of dynamic enzyme changes, in predicting the primary outcome measure. The agreed-upon model will then be validated prospectively.
次要结局
未报告次要终点