Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-03 @ 3:14 AM
Study NCT ID:
NCT07259395
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 363}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the time an ERCP procedure will take between the SWEET tool and the prediction of the endoscopist', 'timeFrame': 'From signing the ICF till end of the ERCP procedure.', 'description': 'Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the prediction by the endoscopist.'}, {'measure': 'Accuracy of the time the ERCP procedure will take between the SWEET tool and real time', 'timeFrame': 'From signing the ICF till end of the ERCP procedure.', 'description': 'Accuracy of the SWEET (SWedish Estimation of ERCP Time) tool for predicting of ERCP preintervention procedure time compared to the measured real time.'}], 'secondaryOutcomes': [{'measure': 'Predictors of Overestimation or Underestimation of ERCP Procedure Time (Difference in Minutes)', 'timeFrame': 'from signing the ICF till end of the ERCP procedure.', 'description': 'Identify factors influencing over/underestimation of ERCP time by the performing endoscopist'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SWEET tool', 'ERCP', 'Endoscopic Retrograde Cholangio-Pancreatography'], 'conditions': ['Endoscopic Retrograde Cholangio-Pancreatography']}, 'descriptionModule': {'briefSummary': '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.\n\nUntil 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients receiving an ERCP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* First or redo-ERCP\n* Intraductal endoscopy\n* ERCPs performed by fellows under supervision\n\nExclusion Criteria:\n\n* ERCPs in altered anatomy\n* ERCPs combined with therapeutic EUS interventions'}, 'identificationModule': {'nctId': 'NCT07259395', 'briefTitle': 'Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.', 'orgStudyIdInfo': {'id': 'TIME SWEET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERCP group', 'interventionNames': ['Procedure: ERCP']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'description': 'Endoscopic retrograde cholangiopancreatography', 'armGroupLabels': ['ERCP group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Helena Degroote', 'role': 'CONTACT', 'email': 'helena.degroote@uzbrussel.be', 'phone': '+32 2 477 60 11'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Helena Degroote, MD, PhD', 'role': 'CONTACT', 'email': 'helena.degroote@uzbrussel.be', 'phone': '+32 2 477 68 11'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}