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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07259395
Enrollment
363
Registered
2025-12-02
Start date
2025-12-31
Completion date
2027-12-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Retrograde Cholangio-Pancreatography

Keywords

SWEET tool, ERCP, Endoscopic Retrograde Cholangio-Pancreatography

Brief summary

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

PROCEDUREERCP

Endoscopic retrograde cholangiopancreatography

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopistFrom 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 timeFrom 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.

Secondary

MeasureTime frameDescription
Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes)from signing the ICF till end of the ERCP procedure.Identify factors influencing over/underestimation of ERCP time by the performing endoscopist

Countries

Belgium

Contacts

Primary ContactHelena Degroote, MD, PhD
helena.degroote@uzbrussel.be+32 2 477 68 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026