Endoscopic Retrograde Cholangio-PancreatographyNCT07259395
Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.
An observational study of Endoscopic Retrograde Cholangio-Pancreatography, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangio-Pancreatography
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 363 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving an ERCP
Who may be able to join
- Age > 18 years
- First or redo-ERCP
- Intraductal endoscopy
- ERCPs performed by fellows under supervision
Who cannot join
- ERCPs in altered anatomy
- ERCPs combined with therapeutic EUS interventions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels
Helena Degroote, +32 2 477 60 11, helena.degroote@uzbrussel.be
About this study
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.
- Being tested
- ERCP
- Keywords
- SWEET tool, ERCP, Endoscopic Retrograde Cholangio-Pancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Endoscopic retrograde cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| ERCP group | Not described Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Identify factors influencing over/underestimation of ERCP time by the performing endoscopist
Measured: from signing the ICF till end of the ERCP procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde Cholangio-PancreatographyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 363 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259395
- Sponsor's protocol ID
- TIME SWEET
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.
- ClinicalTrials.gov ID
- NCT07259395
- Acronym / sponsor ID
- TIME SWEET
- Keywords
- SWEET tool, ERCP, Endoscopic Retrograde Cholangio-Pancreatography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 363 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP group | – | Procedure: ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving an ERCP
Key inclusion criteria (4 listed)
- Age > 18 years
- First or redo-ERCP
- Intraductal endoscopy
- ERCPs performed by fellows under supervision
Key exclusion criteria (2 listed)
- ERCPs in altered anatomy
- ERCPs combined with therapeutic EUS interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPEndoscopic retrograde cholangiopancreatography | Procedure or surgery | ERCP group |
Primary outcome
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 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
Time frame: 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.
1 secondary outcome
Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes)
Time frame: from signing the ICF till end of the ERCP procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Endoscopic Retrograde Cholangio-Pancreatography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Retrograde Cholangio-Pancreatography, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Degroote, MD, PhD (+32 2 477 68 11, helena.degroote@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.