Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-12 @ 6:38 AM
Study NCT ID:
NCT02504034
Status:
UNKNOWN
Last Update Posted:
2015-07-21
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563407', 'term': 'Portal Vein, Cavernous Transformation Of'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Gastrointestinal Bleeding', 'timeFrame': '1 month', 'description': "No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)"}, {'measure': 'Ascites Volume (mL)', 'timeFrame': '1 month', 'description': 'No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)'}]}, 'conditionsModule': {'keywords': ['Portal Vein, Cavernous Transformation Of', 'Hypertension, Portal', 'Radiology, Interventional', 'Portalsystemic shunt'], 'conditions': ['Portal Vein, Cavernous Transformation Of', 'Hypertension, Portal']}, 'descriptionModule': {'briefSummary': 'To evaluate the values of portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with portal hypertention who have enough image information to confirm cavernous transformation of portal vein.\n\nExclusion Criteria:\n\n* Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.'}, 'identificationModule': {'nctId': 'NCT02504034', 'briefTitle': 'Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein', 'orgStudyIdInfo': {'id': 'DORNO3HSYSU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transhepatic portosystemic shunt', 'description': 'Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment', 'interventionNames': ['Procedure: Transhepatic portosystemic shunt', 'Device: 6-French sheath', 'Device: 22-gauge chiba needle', 'Device: 260-cm-long stiff shaft wire', 'Device: Balloon catheter', 'Device: Bare metal stent', 'Device: Covered stent']}], 'interventions': [{'name': 'Transhepatic portosystemic shunt', 'type': 'PROCEDURE', 'description': 'Portal vein (PV) was punctured with a 22-gauge chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract.', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': '6-French sheath', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': '22-gauge chiba needle', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': '260-cm-long stiff shaft wire', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': 'Balloon catheter', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': 'Bare metal stent', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}, {'name': 'Covered stent', 'type': 'DEVICE', 'armGroupLabels': ['Transhepatic portosystemic shunt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zaibo Jiang, MD.', 'role': 'CONTACT', 'email': 'jiangzaibo@aliyun.com', 'phone': '+86 020 85252066'}], 'facility': 'Department of Radiology', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zaibo Jiang, MD.', 'role': 'CONTACT', 'email': 'jiangzaibo@aliyun.com', 'phone': '+86 020 85252066'}], 'overallOfficials': [{'name': 'Zaibo Jiang, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University', 'investigatorFullName': 'Zaibo Jiang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}