Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-21 @ 7:26 AM
Study NCT ID:
NCT00990366
Status:
TERMINATED
Last Update Posted:
2011-10-12
First Post:
2009-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002761', 'term': 'Cholangitis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract 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': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Interim analysis results, study terminated 5/2010', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patency of a biliary stent', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Cholangitis', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antireflux valve', 'biliary obstruction', 'cholangitis', 'biliary stent'], 'conditions': ['Biliary Obstruction', 'Cholangitis']}, 'descriptionModule': {'briefSummary': 'Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-89\n* biliary obstruction in the lower two thirds of the choledochus\n\nExclusion Criteria:\n\n* allergy to contrast media\n* future pancreaticoduodenectomy\n* refusal from the study\n* previous stent'}, 'identificationModule': {'nctId': 'NCT00990366', 'briefTitle': 'Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve', 'orgStudyIdInfo': {'id': '58/180/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'biliary stent without an antireflux valve', 'description': 'patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm', 'interventionNames': ['Device: Cook´s biliary stent with an antireflux stent, normal biliary stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'biliary stent with an antireflux valve', 'description': 'patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm', 'interventionNames': ['Device: Cook´s biliary stent with an antireflux stent, normal biliary stent']}], 'interventions': [{'name': 'Cook´s biliary stent with an antireflux stent, normal biliary stent', 'type': 'DEVICE', 'description': 'arms are assigned randomly by closed envelope method', 'armGroupLabels': ['biliary stent with an antireflux valve', 'biliary stent without an antireflux valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Paulina Salminen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Hanna Vihervaara', 'investigatorAffiliation': 'Turku University Hospital'}}}}