Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 7:37 PM
Study NCT ID:
NCT03031366
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2017-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'TIPS creation using real-time 3D roadmap'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2017-01-21', 'studyFirstSubmitQcDate': '2017-01-21', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': '1 month', 'description': 'number of patients who have received TIPS creation technically successfully'}, {'measure': 'number of punctures', 'timeFrame': '1 month', 'description': 'number of intrahepatic punctures for TIPS creation'}], 'secondaryOutcomes': [{'measure': 'radiographic fluoroscopy time for portal vein entry', 'timeFrame': '1 month', 'description': 'duration of radiographic fluoroscopy for portal vein entry'}, {'measure': 'radiographic fluoroscopy time for the whole procedure', 'timeFrame': '1 month', 'description': 'duration of radiographic fluoroscopy for the whole procedure'}, {'measure': 'procedural time', 'timeFrame': '1 month', 'description': 'procedural time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ncirrhosis complications of portal hypertension requiring TIPS\n\nExclusion Criteria:\n\nnon-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS'}, 'identificationModule': {'nctId': 'NCT03031366', 'briefTitle': 'A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap', 'orgStudyIdInfo': {'id': '3D roadmap for TIPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D roadmap', 'description': 'TIPS was established using 3d roadmap guidance', 'interventionNames': ['Other: 3d roadmap guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional TIPS', 'description': 'conventional TIPS procedure using wedged hepatic venography', 'interventionNames': ['Other: conventional TIPS procedure']}], 'interventions': [{'name': '3d roadmap guidance', 'type': 'OTHER', 'description': 'TIPS was established using 3d roadmap', 'armGroupLabels': ['3D roadmap']}, {'name': 'conventional TIPS procedure', 'type': 'OTHER', 'description': 'conventional TIPS procedure using wedged hepatic venography', 'armGroupLabels': ['conventional TIPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending doctor', 'investigatorFullName': 'luo xuefeng', 'investigatorAffiliation': 'West China Hospital'}}}}