Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT01063634
Status:
UNKNOWN
Last Update Posted:
2010-02-05
First Post:
2010-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-04', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'time to stent obstruction', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malignant biliary obstruction', 'viaduct', 'self-expandable metal stents'], 'conditions': ['To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents']}, 'referencesModule': {'references': [{'pmid': '25590188', 'type': 'DERIVED', 'citation': 'Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with malignant obstruction of the common bile duct', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically proven malignant biliary stenosis\n* signs of biliary obstruction\n* informed consent\n\nExclusion Criteria:\n\n* age under 18\n* Operations like Roux-Y, biliodigestive Anastomosis, BII\n* life expectancy less than 3 months\n* Karnfosky index less than 60%'}, 'identificationModule': {'nctId': 'NCT01063634', 'acronym': 'VIADUCT', 'briefTitle': 'Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Kliniken Ludwigsburg-Bietigheim gGmbH'}, 'officialTitle': 'Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'VIADUCT'}}, 'contactsLocationsModule': {'locations': [{'zip': '71640', 'city': 'Ludwigsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'sabine weinmann', 'role': 'CONTACT', 'email': 'sabine.weinmann@kliniken-lb.de', 'phone': '+49-7141-9994459'}, {'name': 'samuel raad', 'role': 'CONTACT', 'email': 'samuel.raad@kliniken-lb.de', 'phone': '+49-7141-9994464'}, {'name': 'Karel Caca, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}], 'centralContacts': [{'name': 'Karel Caca, Prof. Dr.', 'role': 'CONTACT', 'email': 'karel.caca@kliniken-lb.de', 'phone': '+49-7141-9967201'}, {'name': 'Arthur R Schmidt, Dr.', 'role': 'CONTACT', 'email': 'arthur.schmidt@kliniken-lb.de', 'phone': '+49-7141-9967201'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kliniken Ludwigsburg-Bietigheim gGmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum Ludwigshafen', 'class': 'OTHER'}, {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Medizinische Klinik I, Prof. Dr. K. Caca', 'oldOrganization': 'Klinikum Ludiwgsburg'}}}}