Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT03857958
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction
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': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of stent patency', 'timeFrame': '9 months after randomization.', 'description': 'The period from the insertion of the stent to the point at which stent revision is required.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Hepatobiliary Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.', 'detailedDescription': 'In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure\n\nExclusion Criteria:\n\n* If endoscopy is not possible based on the judgement of the researcher\n* Life expectancy less than 6 months\n* Acute cholecystitis\n* Previous history of percutaneous transhepatic biliary drainage\n* Previous history of metal stent placement for malignant biliary stricture'}, 'identificationModule': {'nctId': 'NCT03857958', 'briefTitle': 'Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction', 'orgStudyIdInfo': {'id': '1812-098-996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FCSEMS', 'description': 'In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.', 'interventionNames': ['Procedure: endoscopic retrograde cholangio-pancreatography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plastic stent', 'description': 'In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.', 'interventionNames': ['Procedure: endoscopic retrograde cholangio-pancreatography']}], 'interventions': [{'name': 'endoscopic retrograde cholangio-pancreatography', 'type': 'PROCEDURE', 'otherNames': ['Plastic stent', 'FCSEMS'], 'description': 'In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.', 'armGroupLabels': ['FCSEMS', 'Plastic stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min su You, MD', 'role': 'CONTACT', 'email': 'bass105@hanmail.net', 'phone': '82-2-2072-2228'}, {'name': 'Woo Hyun Paik, MD, PhD', 'role': 'CONTACT', 'email': 'whpaik@snuh.org', 'phone': '82-2-2072-2228'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Min su You, MD', 'role': 'CONTACT', 'email': 'bass105@hanmail.net', 'phone': '82-2-2072-2228'}, {'name': 'Woo Hyun Paik, MD, PhD', 'role': 'CONTACT', 'email': 'whpaik@snuh.org', 'phone': '82-2-2072-2228'}], 'overallOfficials': [{'name': 'Seoul National University Hospital Seoul National University Hospital, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taewoong Medical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}