Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopist
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is a frequently performed procedure worldwide. The procedure combines endoscopy and X-ray imaging to diagnose and treat problems in the bile and pancreatic ducts, most commonly stones or strictures.
Until the recent publication of Waldthaler et al., there was little evidence about what patient- and procedure-related factors determine a priori the duration of an ERCP. Data from 74 248 ERCPs performed from 2010 to 2019 were extracted from the Swedish National Quality Registry (GallRiks) to identify variables predictive for ERCP time using linear regression analyses and root mean squared error (RMSE) as a loss function. Ten variables were combined to create an estimation tool for ERCP duration: the SWedish Estimation of ERCP Time (SWEET) tool. Having a predictive tool for estimating the procedure time of an invasive endoscopic procedure offers several valuable benefits across clinical, operational, and patient-centered domains: improved scheduling and resource allocation by optimized operating room and endos-copy suite scheduling, reduced delays and less overbooking or underutilization. It helps allocate the right number of staff (nurses, anesthesiologists) based on procedure complexity and minimizes unexpected extensions that lead to staff fatigue or overtime pay.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age > 18 years
- •First or redo-ERCP
- •Intraductal endoscopy
- •ERCPs performed by fellows under supervision
排除标准
- •ERCPs in altered anatomy
- •ERCPs combined with therapeutic EUS interventions
结局指标
主要结局
Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopist
时间窗: From signing the ICF till end of the ERCP procedure.
Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the prediction by the endoscopist.
Accuracy of the time the ERCP procedure will take between the SWEET tool and real time
时间窗: From signing the ICF till end of the ERCP procedure.
Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the measured real time.
次要结局
- Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes)(from signing the ICF till end of the ERCP procedure.)
