Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 9:56 PM
Study NCT ID:
NCT04770857
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between Pain 1 hour after ERCP', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Predictive value of VAS for PEP Predictive value of VAS for PEP', 'timeFrame': '1 hour'}, {'measure': 'Association between VAS level and severity of PEP', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-ERCP Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from \\< 2% up to 40%.\n\nBased upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.\n\nThis study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for ERCP for any reason at the study center will be asked for participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Scheduled for ERCP for any reason\n\nExclusion Criteria:\n\n* Absence of consent\n* Language barrier\n* No endoscopic advance to the papilla vateri\n* Active pancreatitis at the time of the procedure\n* Mental disability'}, 'identificationModule': {'nctId': 'NCT04770857', 'acronym': 'PEP-PREPARE', 'briefTitle': 'Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': 'CTU 19/036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Visual analogue scale', 'type': 'OTHER', 'description': 'Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'contacts': [{'name': 'Nicola Fabian Frei, MD', 'role': 'CONTACT', 'email': 'nicolafabian.frei@kssg.ch', 'phone': '+41 71 494 99 68'}], 'facility': 'Kantonsspital Sankt Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'centralContacts': [{'name': 'Nicola Fabian Frei, MD', 'role': 'CONTACT', 'email': 'nicolafabian.frei@kssg.ch', 'phone': '+41 71 494 99 68'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicola Frei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nicola Frei', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}