Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-28 @ 8:39 PM
Study NCT ID:
NCT02114320
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001651', 'term': 'Cholestasis, Extrahepatic'}], 'ancestors': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-04-12', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate and procedural time of EUS-BD using metallic stents', 'timeFrame': 'six months', 'description': 'Measure the successful rate of biliary drainage using metallic stents and procedural time'}], 'secondaryOutcomes': [{'measure': 'Complication rate of EUS-BD using metallic stents', 'timeFrame': 'six months', 'description': 'Measure the complication rate of EUS-BD using metallic stents'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic ultrasonography', 'Biliary drainage', 'Metal stent'], 'conditions': ['Cholestasis, Extrahepatic']}, 'descriptionModule': {'briefSummary': 'Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.\n\nSince endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.\n\nUp to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.', 'detailedDescription': 'We investigated the efficacy and safety of EUS-BD using partially covered (hybrid) metallic stent with a dedicated introducer for EUS-BD, or fully covered antimigration metallic stents in malignant biliary obstruction after failed conventional ERCP as a prospective multicenter study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* malignant biliary obstruction\n* Inoperable state\n* age \\> 18 yrs\n* failed primary ERCP\n\nExclusion Criteria:\n\n* uncontrolled coagulopathy\n* refuse to this study enrollment'}, 'identificationModule': {'nctId': 'NCT02114320', 'briefTitle': 'Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Multicenter Study of EUS-guided Biliary Drainage Using Partially Covered With a Dedicated Introducer or Fully Covered Antimigration Metallic Stents', 'orgStudyIdInfo': {'id': 'EUS-BD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EUS-BD-1', 'description': 'EUS-BD-1 inserts a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD', 'interventionNames': ['Device: EUS-BD']}, {'type': 'EXPERIMENTAL', 'label': 'EUS-BD-2', 'description': 'EUS-BD-2 inserts a fully covered self-expanding metallic stent', 'interventionNames': ['Device: EUS-BD']}], 'interventions': [{'name': 'EUS-BD', 'type': 'DEVICE', 'otherNames': ['EUS-BD-1: a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD', 'EUS-BD-2: a fully covered self-expanding metallic stent'], 'description': 'EUS-guided hepaticogastrostomy (EUS-HG) will be performed in patients with hilar stricture or altered anatomy such as Roux-en-Y anastomosis, and EUS-guided choledochoduodenostomy (EUS-CD) will be performed in patients with mid to distal extrahepatic bile duct strictures. Because EUS-guided rendezvous technique can be attempted only in patients in whom the papilla is endoscopically accessible. Following bile duct puncture using a 19-gauge fine needle, one-step or graded tract dilatation will be performed. Then, finally we insert a partially or fully covered metallic stent.', 'armGroupLabels': ['EUS-BD-1', 'EUS-BD-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330-721', 'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Tae Hoon Lee', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Woo Hyun Paik', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}], 'overallOfficials': [{'name': 'Do Hyun Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Do Hyun Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}