Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01393067
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2011-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-27', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of interventions (ERCP) to attain resolution of stenosis', 'timeFrame': 'up to one year', 'description': 'Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS'}], 'secondaryOutcomes': [{'measure': 'Occurence and severity of complications related to the endoscopic procedures', 'timeFrame': 'up to 2 months after ERCP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cSEMS', 'NEPS', 'ERCP', 'biliary stricture', 'biliary stenosis', 'liver transplantation'], 'conditions': ['Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '18294506', 'type': 'BACKGROUND', 'citation': 'Kahaleh M, Behm B, Clarke BW, Brock A, Shami VM, De La Rue SA, Sundaram V, Tokar J, Adams RB, Yeaton P. Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video). Gastrointest Endosc. 2008 Mar;67(3):446-54. doi: 10.1016/j.gie.2007.06.057.'}, {'pmid': '19693751', 'type': 'BACKGROUND', 'citation': 'Wang AY, Ellen K, Berg CL, Schmitt TM, Kahaleh M. Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data - a case series. Endoscopy. 2009 Sep;41(9):781-6. doi: 10.1055/s-0029-1215050. Epub 2009 Aug 19.'}, {'pmid': '21618151', 'type': 'BACKGROUND', 'citation': 'Phillips MS, Bonatti H, Sauer BG, Smith L, Javaid M, Kahaleh M, Schmitt T. Elevated stricture rate following the use of fully covered self-expandable metal biliary stents for biliary leaks following liver transplantation. Endoscopy. 2011 Jun;43(6):512-7. doi: 10.1055/s-0030-1256389. Epub 2011 May 26.'}, {'pmid': '28302527', 'type': 'DERIVED', 'citation': 'Tal AO, Finkelmeier F, Filmann N, Kylanpaa L, Udd M, Parzanese I, Cantu P, Dechene A, Penndorf V, Schnitzbauer A, Friedrich-Rust M, Zeuzem S, Albert JG. Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial. Gastrointest Endosc. 2017 Dec;86(6):1038-1045. doi: 10.1016/j.gie.2017.03.009. Epub 2017 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).', 'detailedDescription': 'This is a multi-center randomised trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post-OLT stenosis of the bilio-biliary anastomotic\n\nExclusion Criteria:\n\n* non-anastomotic stricture\n* stent implatation technically not feasible'}, 'identificationModule': {'nctId': 'NCT01393067', 'briefTitle': 'cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation', 'orgStudyIdInfo': {'id': '148/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group NEPS', 'description': 'implantation of multiple non-expandable plastic stents', 'interventionNames': ['Device: Non-expandable plastic stent (plastic endoprosthesis)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group cSEMS', 'description': 'implantation of a self-expandable metal stent (cSEMS)', 'interventionNames': ['Device: Covered self-expandable metal stent (cSEMS)']}], 'interventions': [{'name': 'Non-expandable plastic stent (plastic endoprosthesis)', 'type': 'DEVICE', 'otherNames': ['OptiMed, Boston Scientifiv, MTW'], 'description': 'plastic stent (plastic endoprosthesis)', 'armGroupLabels': ['study group NEPS']}, {'name': 'Covered self-expandable metal stent (cSEMS)', 'type': 'DEVICE', 'otherNames': ['Niti-S biliary stent, fully covered'], 'description': 'Removable, covered self-expandable metal stent (cSEMS)', 'armGroupLabels': ['group cSEMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '340', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Department of Internal Medicine I', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'University of Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Jörg Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Johann Wolfgang Goethe University Hospitals.', 'investigatorFullName': 'Jorg Albert', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}