Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-26 @ 1:23 PM
Study NCT ID:
NCT01148693
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2010-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r.sotudemanesh@gmail.com', 'phone': '(+98 21) 82414000', 'title': 'Dr. Rasoul sotoudehmanesh', 'phoneExt': '82415000', 'organization': 'Tehran medical university of science'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No limitation other than small sample size'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gentamicin', 'description': 'participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Cholangitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gentamicin', 'description': 'patients for whom 10m/10cc of gentamicin is added to contrast during ERCP'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients for whom distilled water is added to contrast during ERCP'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gentamicin', 'description': 'participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Attempts for cannulation were failed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Between December 2009 and October 2010 all patients with non-calculus biliary obstructions including cholangiocarcinoma, pancreatic cancer, sclerosing cholangitis, postsurgical benign biliary strictures and biliary stenosis due to metastatic cancers to biliary tree who were candidate for palliative stenting, were included in this study.', 'preAssignmentDetails': 'Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gentamicin', 'description': 'participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.59', 'spread': '15.082', 'groupId': 'BG000'}, {'value': '66.74', 'spread': '14.145', 'groupId': 'BG001'}, {'value': '64.62', 'spread': '14.533', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-18', 'studyFirstSubmitDate': '2010-06-19', 'resultsFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-25', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cholangitis', 'timeFrame': '72 hours', 'description': 'After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis'], 'conditions': ['Cholangitis']}, 'referencesModule': {'references': [{'pmid': '23081843', 'type': 'DERIVED', 'citation': 'Norouzi A, Khatibian M, Afroogh R, Chaharmahali M, Sotoudehmanesh R. The effect of adding gentamicin to contrast media for prevention of cholangitis after biliary stenting for non-calculous biliary obstruction, a randomized controlled trial. Indian J Gastroenterol. 2013 Jan;32(1):18-21. doi: 10.1007/s12664-012-0208-y. Epub 2012 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-calculus biliary obstruction who need palliative treatment\n\nExclusion Criteria:\n\n* Fever (\\> 37.8 Celsius)\n* Leukocytosis (WBC \\> 10,000 /mm3)\n* Not candidate for surgical cure of obstruction'}, 'identificationModule': {'nctId': 'NCT01148693', 'briefTitle': 'Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting', 'orgStudyIdInfo': {'id': 'DDRC-88/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gentamicin', 'description': 'adding 10mg gentamicin to every 10 ml of contrast media', 'interventionNames': ['Drug: gentamicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical placebo', 'interventionNames': ['Drug: gentamicin', 'Drug: Placebo']}], 'interventions': [{'name': 'gentamicin', 'type': 'DRUG', 'otherNames': ['Brand name: Gentamicin'], 'description': '10mg per 10ml of contrast media', 'armGroupLabels': ['Placebo', 'gentamicin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Distilled water', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1411713135', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'TUMS Digestive Disease Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Rasoul Sotudemanesh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tehran Medical University of Medical Science associate professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'gastroenterology fellow in DDRC', 'investigatorFullName': 'Alireza Norouzi', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}