Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-19 @ 5:19 PM
Study NCT ID:
NCT02290769
Status:
SUSPENDED
Last Update Posted:
2023-03-22
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 292}}, 'statusModule': {'whyStopped': 'Hospital administrative problems', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of cannulation', 'timeFrame': '8 hours from intervention', 'description': 'Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database'}], 'secondaryOutcomes': [{'measure': 'Incidence of post ERCP pancreatitis', 'timeFrame': '8 hours post ERCP', 'description': 'Incidence of post ERCP pancreatitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Guide wire cannulation ERCP', 'Time of cannulation', 'Rapid exchange guide wire', 'Guide wire'], 'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.', 'detailedDescription': 'In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.\n\nAim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication to primary ERCP\n* ASA (American Society of Anesthesiologists) 1, 2, 3\n\nExclusion Criteria:\n\n* pancreas neoplasia\n* pancreatitis\n* ampulloma\n* duodenum stenosis\n* under mucous membrane haematoma'}, 'identificationModule': {'nctId': 'NCT02290769', 'acronym': 'RELG', 'briefTitle': 'Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '382 - 072014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short guide wire rapid exchange', 'description': 'Use of short guide wire rapid exchange to guide the cannulation during primary ERCP', 'interventionNames': ['Device: Short guide wire rapid exchange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long guide wire', 'description': 'Use of long wire to guide the cannulation during primary ERCP', 'interventionNames': ['Device: Long guide wire']}], 'interventions': [{'name': 'Short guide wire rapid exchange', 'type': 'DEVICE', 'description': 'Use of short guide wire rapid exchange to guide the cannulation during primary ERCP', 'armGroupLabels': ['Short guide wire rapid exchange']}, {'name': 'Long guide wire', 'type': 'DEVICE', 'description': 'Use of long wire to guide the cannulation during primary ERCP', 'armGroupLabels': ['Long guide wire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Niguarda Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Francesco Pugliese, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Niguarda Ca' Granda Hospital"}, {'name': 'Edoardo Forti, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Niguarda Ca' Granda Hospital"}, {'name': 'Raffaele Manta, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Niguarda Ca' Granda Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}