Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02232451
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}, {'id': 'D002404', 'term': 'Catheterization'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of the incidence of PEP', 'timeFrame': 'loop20216'}], 'secondaryOutcomes': [{'measure': 'The evaluation of CBD percentage cannulation.', 'timeFrame': 'loop20216'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['loop', 'ERCP', 'cannulation', 'biliary', 'wire'], 'conditions': ['Complications of Surgical and Medical Care: General Terms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.', 'detailedDescription': 'Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.\n\nType of study: Multicentric, prospective and randomized trial\n\nPatients: PEP high-risk patients underwent ERCP for benign biliary pathology\n\nNumber of patients: 320 patients (160 for each group)\n\nAim:\n\nPrimary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high risk patients for post-ERCP pancreatitis\n\nExclusion Criteria:\n\n* age \\< 18 yrs\n* allergy to the contrast medium\n* previous surgery\n* neoplastic bilio-pancreatic disease\n* previous EBS'}, 'identificationModule': {'nctId': 'NCT02232451', 'acronym': 'loop', 'briefTitle': 'Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Paolo'}, 'officialTitle': 'Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients', 'orgStudyIdInfo': {'id': 'loop20216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERCP with loop tip wire', 'description': 'ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.', 'interventionNames': ['Device: ERCP with loop tip wire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERCP for cannulation', 'description': 'ERCP for cannulation of CBD with traditional technique', 'interventionNames': ['Device: ERCP for cannulation']}], 'interventions': [{'name': 'ERCP with loop tip wire', 'type': 'DEVICE', 'description': 'Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation', 'armGroupLabels': ['ERCP with loop tip wire']}, {'name': 'ERCP for cannulation', 'type': 'DEVICE', 'description': 'Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation', 'armGroupLabels': ['ERCP for cannulation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enzo Masci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital San Paolo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Paolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Gastrointestinal Endoscopy', 'investigatorFullName': 'Enzo Masci', 'investigatorAffiliation': 'Azienda Ospedaliera San Paolo'}}}}