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Recruiting NCT07259395

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

— Observational Endoscopic Retrograde Cholangio-Pancreatography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ERCP.
Who it may be relevant to
Registry conditions: Endoscopic Retrograde Cholangio-Pancreatography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure ERCP
    Endoscopic retrograde cholangiopancreatography

Primary outcome measures

  • Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopist [Time frame: From signing the ICF till end of the ERCP procedure.]
  • Accuracy of the time the ERCP procedure will take between the SWEET tool and real time [Time frame: From signing the ICF till end of the ERCP procedure.]
Secondary outcome measures (1)
  • Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes) [Time frame: from signing the ICF till end of the ERCP procedure.]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • First or redo-ERCP
  • Intraductal endoscopy
  • ERCPs performed by fellows under supervision

Exclusion criteria

  • ERCPs in altered anatomy
  • ERCPs combined with therapeutic EUS interventions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • UZ Brussel — Brussels

Identifiers

NCT: NCT07259395 · TIME SWEET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗