Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Cannulation
研究概览
简要总结
The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.
详细描述
Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes.
The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years old
- •Patients with native papilla
- •Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography
排除标准
- •Age <18 years old
- •Unable to obtain informed consent
- •Altered upper gastrointestinal surgical anatomy
- •Patients with percutaneous transhepatic biliary drainage catheters
- •Prior history of ERCP
研究组 & 干预措施
Disposable (single-use) duodenoscope
This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).
干预措施: endoscopic retrograde cholangiopancreatography (Device)
Reusable duodenoscope
This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).
干预措施: endoscopic retrograde cholangiopancreatography (Device)
结局指标
主要结局
Cannulation
时间窗: 1 day
The ease of cannulation of the desired duct (biliary or pancreatic), as measured by the total number of cannulation attempts to achieve successful cannulation of the desired duct.
次要结局
- Rate of cross-over(1 day)
- Time taken for cannulation(1 day)
- Total duration of the procedure(1 day)
- Rate of adverse events(7 days and 30 days)
- Rate of use of advanced cannulation techniques(1 day)
- Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope(1 day)
- Ease of completion of interventions(1 day)