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

NCT ID: NCT07259395

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangio-Pancreatography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ERCP group

ERCP

Intervention Type PROCEDURE

Endoscopic retrograde cholangiopancreatography

Interventions

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ERCP

Endoscopic retrograde cholangiopancreatography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Helena Degroote, MD, PhD

Role: CONTACT

+32 2 477 68 11

Facility Contacts

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Helena Degroote

Role: primary

+32 2 477 60 11

Other Identifiers

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TIME SWEET

Identifier Type: -

Identifier Source: org_study_id

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