跳至主要内容
临床试验/NCT07259395
NCT07259395招募中不适用

Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2025年12月1日最近更新:

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

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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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