Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-04-12 @ 5:00 AM
Study NCT ID:
NCT02297750
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of biliary cannulation', 'timeFrame': '10 minutes after randomization', 'description': 'The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.'}], 'secondaryOutcomes': [{'measure': 'Success of biliary cannulation', 'timeFrame': '2 days after the procedure', 'description': 'Number of attempts required for successful biliary cannulation'}, {'measure': 'Time to successful biliary cannulation', 'timeFrame': '2 days after the procedure'}, {'measure': 'Post-ERCP pancreatitis', 'timeFrame': '2 days after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.'], 'conditions': ['Endoscopic Retrograde Cholangiopancreatography']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.', 'detailedDescription': 'Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing ERCP with primary intent to cannulate the bile duct\n2. Written informed consent\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Non-naive papilla (previous sphincterotomy)\n3. Surgically altered anatomy\n4. Known/suspected pancreas divisum\n5. Suspected SOD/biliary manometry\n6. Prior ERCP/stent within 3 months\n7. ERCP performed in the Operating Room or at Duke North\n8. Pregnancy/breast-feeding'}, 'identificationModule': {'nctId': 'NCT02297750', 'briefTitle': 'Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP', 'orgStudyIdInfo': {'id': 'Pro00033706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single wire technique', 'description': 'single wire technique in patients undergoing ERCP with biliary cannulation', 'interventionNames': ['Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double wire technique', 'description': 'double-wire technique in patients undergoing ERCP with biliary cannulation', 'interventionNames': ['Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation']}], 'interventions': [{'name': 'double-wire technique in patients undergoing ERCP with biliary cannulation', 'type': 'PROCEDURE', 'armGroupLabels': ['Double wire technique']}, {'name': 'single-wire technique in patients undergoing ERCP with biliary cannulation', 'type': 'PROCEDURE', 'armGroupLabels': ['single wire technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Mahfuzul Haque, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}