Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 11:28 AM
Study NCT ID:
NCT01622803
Status:
WITHDRAWN
Last Update Posted:
2016-04-26
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D041781', 'term': 'Jaundice, Obstructive'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Patients enrollment problem', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-24', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time taken to insert bilateral stent', 'timeFrame': 'After the ERCP procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bile Duct Neoplasm', 'Obstructive Jaundice']}, 'descriptionModule': {'briefSummary': 'Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.\n\nBilateral drainage is more physiologic and have more long patency than unilateral drainage.\n\nThere are two methods of bilateral drainage: Y-stent and side by side.\n\nHowever there are no clinical data about comparing the effectiveness of these two methods.\n\nTherefore the investigators want to compare the clinical outcomes of two methods:\n\nY-stent and side by side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* patient who have obstructive jaundice (bilirubin \\> 2.0mg/dl) due to hilar malignancy\n\nExclusion Criteria:\n\n* patients with endoscopic retrograde cholangiogram is not possible\n* bleeding tendency (PT INR \\> 1.5, platelet \\< 50,000)\n* poor general condition (ECOG 3-4) or cardiopulmonary deterioration\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01622803', 'briefTitle': 'Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction', 'orgStudyIdInfo': {'id': 'KH0LEE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'parallel stent', 'description': 'parallel stent insertion group', 'interventionNames': ['Procedure: parallel stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Y-stent', 'description': 'Y-stent insertion group', 'interventionNames': ['Device: Y-stent (BONASTENT M-Hilar)']}], 'interventions': [{'name': 'parallel stent', 'type': 'PROCEDURE', 'otherNames': ['bilateral pig tail plastic stent'], 'description': 'bilateral parallel stent insertion (right and left side)', 'armGroupLabels': ['parallel stent']}, {'name': 'Y-stent (BONASTENT M-Hilar)', 'type': 'DEVICE', 'otherNames': ['BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea'], 'description': 'Bilateral Y-stent insertion (stent in stent type)', 'armGroupLabels': ['Y-stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kwang hyuck Lee, MD, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Kwang Hyuck Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}