Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 3:35 PM
Study NCT ID:
NCT01002404
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of deep biliary cannulation', 'timeFrame': 'October 2010'}], 'secondaryOutcomes': [{'measure': 'Frequency of post-ERCP pancreatitis', 'timeFrame': 'October 2010'}, {'measure': 'time spent to deep biliary cannulation', 'timeFrame': 'October 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ERCP', 'deep biliary cannulation', 'guide wire cannulation', 'post-ERCP pancreatitis', 'Success of deep biliary cannulation', 'Rate of post-ERCP pancreatitis', 'Time used to deep biliary cannulation'], 'conditions': ['Deep Biliary Cannulation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.', 'detailedDescription': 'Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the need for ERCP assessed by a specialist in gastrointestinal surgery\n\nExclusion Criteria:\n\n* prior sphincterotomy\n* age under 18\n* age over 90\n* contrast media allergy\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01002404', 'briefTitle': 'The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?', 'orgStudyIdInfo': {'id': '23/180/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'angled tipped guide wire', 'description': 'angled tipped guide wire used to deep biliary cannulation', 'interventionNames': ['Procedure: angled and straight tipped guide wire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'straight tipped guidewire', 'description': 'straight guide wire used to deep biliary cannulation', 'interventionNames': ['Procedure: angled and straight tipped guide wire']}], 'interventions': [{'name': 'angled and straight tipped guide wire', 'type': 'PROCEDURE', 'description': 'Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.', 'armGroupLabels': ['angled tipped guide wire', 'straight tipped guidewire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Hanna R Vihervaara', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Juha Grönroos, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Paulina Salminen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'gastrointestinal surgeon', 'investigatorFullName': 'Hanna Vihervaara', 'investigatorAffiliation': 'Turku University Hospital'}}}}