Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-04-04 @ 3:45 AM
Study NCT ID:
NCT02255669
Status:
UNKNOWN
Last Update Posted:
2015-02-12
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of stent patency', 'timeFrame': 'From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From the date of randomization until the date of death from any cause, assessed upto 12 months'}, {'measure': 'stent occlusion rate', 'timeFrame': 'From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months'}, {'measure': 'stent related complication', 'timeFrame': 'From the date of randomization until the date of first documented stent related complication, assessed up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Biliary Tract Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.', 'detailedDescription': 'Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.\n\nThe aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.\\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal\n\nExclusion Criteria:\n\n* 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\\>1.5, Platelet\\<50000) 4.expected survival \\> 3 months based on Karnofsky performance score 5.duodenal stricture"}, 'identificationModule': {'nctId': 'NCT02255669', 'briefTitle': 'Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction', 'orgStudyIdInfo': {'id': '2014-07-187-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'partially covered SEMS', 'description': 'Deployment of Partially covered biliary self expandable metal stent', 'interventionNames': ['Device: partially covered SEMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fully covered SEMS', 'description': 'Deployment of Fully covered biliary self expandable metal stent', 'interventionNames': ['Device: fully covered SEMS']}], 'interventions': [{'name': 'partially covered SEMS', 'type': 'DEVICE', 'otherNames': ['Insertion of partially covered SEMS (PCSEMS)'], 'description': 'Used for palliation of inoperable malignant distal bile duct obstruction.', 'armGroupLabels': ['partially covered SEMS']}, {'name': 'fully covered SEMS', 'type': 'DEVICE', 'otherNames': ['Insertion of fully covered SEMS (FCSEMS)'], 'description': 'Used for palliation of inoperable malignant distal bile duct obstruction.', 'armGroupLabels': ['fully covered SEMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Kyun Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jongk.lee@samsung.com', 'phone': '81-2-3410-3409'}], 'facility': 'Samsung Medical Cencer', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jong Kyun Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'leejk@skku.edu', 'phone': '82-2-3410-3409'}], 'overallOfficials': [{'name': 'Jong Kyun Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Cencer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}