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

NCT07259395 | Recruiting

• 1 other identifier: TIME SWEET
• Study Type: observational
• Target: 363
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Retrograde Cholangio-Pancreatography

Keywords

SWEET tool; ERCP; Endoscopic Retrograde Cholangio-Pancreatography

Outcome Measures

Primary Outcomes (2)

• Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopist

  Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the prediction by the endoscopist.

  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

  Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the measured real time.

  From signing the ICF till end of the ERCP procedure.

Secondary Outcomes (1)

• Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes)

  from signing the ICF till end of the ERCP procedure.

Study Arms (1)

ERCP group

Procedure: ERCP

Interventions

ERCP PROCEDURE

Endoscopic retrograde cholangiopancreatography

ERCP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving an ERCP

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Belgium

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Helena Degroote, MD, PhD

CONTACT

+32 2 477 68 11; helena.degroote@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)