National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- Timing of cholangioscopy in the management of complex biliary pathologies.
研究概览
简要总结
Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) remain fundamental tools for the diagnosis and treatment of many pancreatobiliary diseases.
However, there are situations in which these procedures face limitations, such as the evaluation of indeterminate ductal strictures or the management of complex choledocholithiasis.
Direct visualization of the biliary and pancreatic ducts has proven to be a useful and effective alternative in such cases. It also has a safety profile comparable to conventional ERCP, with only a slight increase in the incidence of adverse events.
Nevertheless, due to the associated increase in costs, most centers have adopted a stepwise approach in their diagnostic and therapeutic algorithms, using this technique only after multiple ERCPs.
Although the evidence is still limited, recent studies suggest that early use of direct cholangiopancreatoscopy could be a cost-effective strategy due to its increased efficacy.
In this regard, collecting data on direct cholangiopancreatoscopy would be of interest to generate robust conclusions on cost-effectiveness in routine clinical practice.
This study aims to objectively assess the real-world use of direct cholangiopancreatoscopy in our setting, with the goal of confirming technical aspects, efficacy, and safety, and ultimately conducting cost-effectiveness evaluations to determine the optimal point in the algorithm at which this technique should be introduced.
详细描述
Endoscopic procedures, more specifically endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), remain fundamental in the study and/or treatment of many pancreatic and biliary tract diseases.
However, there are certain situations in which these procedures face limitations, whether due to the characteristics of the pathology itself or the technique's constraints. This is the case, for example, in the evaluation of indeterminate ductal strictures or the management of complex choledocholithiasis, where the diagnostic or therapeutic yield is often suboptimal.
Direct visualization of the biliary and pancreatic ducts has been shown to be a useful and effective alternative in such scenarios. Its safety profile is similar to that of conventional ERCP, with only a slight increase in the incidence of adverse events.
Despite this, the increased costs associated with this technique have led most centers to adopt a stepwise approach in their clinical algorithms. In general, conventional ERCP is used initially, and direct cholangiopancreatoscopy is only considered after several failed ERCPs.
While the economic evidence remains limited, recent studies suggest that early implementation of this technique could be a cost-effective solution, due to its high efficacy and the potential reduction in the total number of procedures required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.
- •Be over 18 years of age.
- •Provide signed informed consent.
排除标准
- •Age under 18 years.
- •Lack of availability of signed informed consent.
- •Impossibility of follow-up.
结局指标
主要结局
Timing of cholangioscopy in the management of complex biliary pathologies.
时间窗: Through study completion, an average of 1 year.
To determine the optimal timing for the use of direct cholangiopancreatoscopy in the management of complex choledocholithiasis and the evaluation of indeterminate biliary strictures.
次要结局
- Diagnostic and therapeutic success rate in cholangioscopy.(Through study completion, an average of 1 year)
- Incidence of procedure-related adverse events following cholangioscopy.(1 month)
- Incremental cost-effectiveness ratio of early cholangioscopy compared to repeated ERCPs.(Through study completion, an average of 1 year.)